LKF c501 Cobas 6000 Analyzer Series User Guide

September 11, 2024
LKF

c501 Cobas 6000 Analyzer Series

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Product Specifications

  • Manufacturer: LKF GmbH
  • Accreditation: DIN EN ISO 17025:2018 by DAkkS
  • Model: Roche Cobas 6000 c501, Siemens BCS-XP, Siemens Atellica
    NEPH 630

Product Usage Instructions

Serum Analysis

For serum analysis, follow the steps below:

  1. Collect the serum sample as per standard procedures.

  2. Place the serum sample in the designated compartment of the
    analyzer.

  3. Run the photometric or chromogenic tests according to the
    specific SOP version provided.

Urine Analysis

For urine analysis, follow these instructions:

  1. Collect the urine sample in a clean container.

  2. If required, transfer the urine to the appropriate section for
    analysis.

  3. Perform the immunoturbidimetric or reflectometric tests as
    needed.

Frequently Asked Questions (FAQ)

Q: What accreditation does LKF GmbH hold?

A: LKF GmbH is accredited according to DIN EN ISO 17025:2018 by
DAkkS.

Q: Which models are supported by the product?

A: The supported models include Roche Cobas 6000 c501, Siemens
BCS-XP, and Siemens Atellica NEPH 630.

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Note:
LKF GmbH is accredited according to DIN EN ISO 17025:2018 by the German Accreditation Body DAkkS.
The test procedures listed below are accredited within the flexible scope of the accreditation. Within the given type of examination marked with *), the LKF GmbH is permitted to without being required to inform and obtain prior approval from DAkkS, the free choice of standards or equivalent examination procedures. Within the given type of examination marked with **), the LKF GmbH is permitted to without being required to inform and obtain prior approval from DAkkS, the modification, development and refinement of examination procedures. Assays that are not listed on the Annex to the Accreditation Certificate from 07.01.2022 but are accredited within the flexible scope are marked in green.
Prüfgebiet: Klinische Chemie

Prüfart: Spektrometrie (UV-/VIS-Photometrie)*

Analyt (Messgröße)
Albumin Alkalische Phosphatase Amylase Antithrombin III (Aktivität) Bicarbonat Bilirubin direkt Bilirubin total Calcium Cholesterol Cholesterol-HDL direkt Cholesterol-LDL direkt Cholinesterase CK NAC-aktiviert CK-MB NAC- aktiviert Creatinine (enzymatisch) Creatinine (Jaffé)

Prüfmaterial (Matrix)
Serum Serum Serum Citratplasma Serum Serum Serum Serum/Urin Serum Serum Serum Serum Serum Serum Serum/Urin Serum

Prüftechnik
Photometrie Photometrie Photometrie Chromogener Farbtest Photometrie Photometrie Photometrie Photometrie Photometrie Photometrie Photometrie Photometrie Photometrie Photometrie Photometrie Photometrie

Anweisung/Version
SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0133 / V 10.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0

Gerät
Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Siemens BCS- XP Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501

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Analyt (Messgröße)
Eisen Freie Fettsäuren Gamma-GT Gerinnungsfaktor VIII Gerinnungsfaktor IX GLDH Glukose GOT (ASAT) GPT (ALAT) Harnsäure Harnstoff N HBDH LDH Lipase Magnesium P-Amylase Phosphat (anorg.) Protein, gesamt Triglyceride

Prüfmaterial (Matrix)
Serum Serum Serum Citratplasma Citratplasma Serum Serum/Plasma/Urin Serum Serum Serum/Urin Serum/Urin Serum Serum Serum Serum/Urin Serum Serum/Urin Serum Serum

Prüftechnik
Photometrie Photometrie Photometrie Chromogener Farbtest Chromogener Farbtest Photometrie Photometrie Photometrie Photometrie Photometrie Photometrie Photometrie Photometrie Photometrie Photometrie Photometrie Photometrie Photometrie Photometrie

Anweisung/Version
SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0133 / V 10.0 SOP-0133 / V 10.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0

Gerät
Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Siemens BCS- XP Siemens BCS-XP Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501

Prüfart: Spektrometrie (Nephelometrie)*

Analyt (Messgröße)
alpha2-Makroglobulin Cystatin C

Prüfmaterial (Matrix)
Serum
Serum

Prüftechnik
Immunnephelometrie Immunnephelometrie

Anweisung/Version
SOP-0184 / V 4.0 SOP-0184 / V 4.0

Gerät
Siemens Atellica NEPH 630 Siemens Atellica NEPH 630

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Analyt (Messgröße)
Bilirubin Erythrozyten Glukose Hämoglobin Keton Leukozyten Nitrit pH- Wert Protein Spezifisches Gewicht Urobilinogen

Prüfmaterial (Matrix)
Urin Urin Urin Urin Urin Urin Urin Urin Urin Urin Urin

Prüftechnik
Reflektometrie Reflektometrie Reflektometrie Reflektometrie Reflektometrie Reflektometrie Reflektometrie Reflektometrie Reflektometrie Reflektometrie Reflektometrie

Prüfart: Spektrometrie (Turbidimetrie/Immunturbidimetrie)*

Analyt (Messgröße)
Albumin alpha1-Mikroglobulin Apolipoprotein B Calprotektin CRP Lipoprotein (a) HbA1c Prealbumin Protein Rheumafaktor saures-alpha1-Glykoprotein Transferrin

Prüfmaterial (Matrix)
Urin Urin Serum Stuhl Serum Serum Vollblut Serum Urin Serum Serum Serum

Prüftechnik
Immunturbidimetrie Immunturbidimetrie Immunturbidimetrie Immunturbidimetrie Immunturbidimetrie Immunturbidimetrie Immunturbidimetrie Immunturbidimetrie Turbidimetrie Immunturbidimetrie Immunturbidimetrie Turbidimetrie

Anweisung/Version
SOP-0126 / V 10.0 SOP-0126 / V 10.0 SOP-0126 / V 10.0 SOP-0126 / V 10.0 SOP-0126 / V 10.0 SOP-0126 / V 10.0 SOP-0126 / V 10.0 SOP-0126 / V 10.0 SOP-0126 / V 10.0 SOP-0126 / V 10.0 SOP-0126 / V 10.0

Gerät
Cobas u 411 Cobas u 411 Cobas u 411 Cobas u 411 Cobas u 411 Cobas u 411 Cobas u 411 Cobas u 411 Cobas u 411 Cobas u 411 Cobas u 411

Anweisung/Version
SOP-0138 / V 13.0 SOP-0184 / V 4.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0

Gerät
Roche Cobas 6000 c501 Siemens Atellica NEPH 630 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501

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Analyt (Messgröße)
Chlorid Kalium Natrium

Prüfmaterial (Matrix)
Serum/Urin
Serum/Urin Serum/Urin

Prüftechnik
Potentiometrie (ISE) Potentiometrie (ISE) Potentiometrie (ISE)

Anweisung/Version
SOP-0138 / V 13.0 SOP-0138 / V 13.0 SOP-0138 / V 13.0

Gerät
Roche Cobas 6000 c501 Roche Cobas 6000 c501 Roche Cobas 6000 c501

Prüfart: Durchflusszytometrie*

Analyt (Messgröße)
Blutbild, Groß Blutbild, Klein Differentialblutbild, maschinell NRBC (kernhaltige Erythrozytenvorstufen)
Retikulozyten Reticulozyten Hämoglobin Thrombozyten

Prüfmaterial (Matrix)
EDTA-Blut EDTA-Blut EDTA-Blut EDTA-Blut
EDTA-Blut EDTA-Blut EDTA-Blut

Prüftechnik
Durchflusszytometrie Durchflusszytometrie Durchflusszytometrie Durchflusszytometrie

Anweisung/Version
SOP-0148 / V 7.0 SOP-0148 / V 7.0 SOP-0148 / V 7.0 SOP-0148 / V 7.0

Gerät
Sysmex XN-1000 Sysmex XN-1000 Sysmex XN-1000 Sysmex XN-1000

Durchflusszytometrie Durchflusszytometrie Durchflusszytometrie

SOP-0148 / V 7.0 SOP-0148 / V 7.0 SOP-0148 / V 7.0

Sysmex XN-1000 Sysmex XN-1000 Sysmex XN-1000

Prüfart: Koagulometrie*

Analyt (Messgröße)
Fibrinogen Gerinnungsfaktor II Gerinnungsfaktor V Gerinnungsfaktor VII Gerinnungsfaktor VIII Gerinnungsfaktor VIII Inhibitor Gerinnungsfaktor IX

Prüfmaterial (Matrix)
Citratplasma Citratplasma Citratplasma Citratplasma Citratplasma Citratplasma Citratplasma

Prüftechnik
Koagulometrie Koagulometrie Koagulometrie Koagulometrie Koagulometrie Koagulometrie Koagulometrie

Anweisung/Version
SOP-0133 / V 10.0 SOP-0133 / V 10.0 SOP-0133 / V 10.0 SOP-0133 / V 10.0 SOP-0133 / V 10.0 SOP-0133 / V 10.0 SOP-0133 / V 10.0

Gerät
Siemens BCS-XP Siemens BCS-XP Siemens BCS-XP Siemens BCS-XP Siemens BCS-XP Siemens BCS-XP Siemens BCS-XP

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Analyt (Messgröße)
Gerinnungsfaktor IX Inhibitor Gerinnungsfaktor X Lupus-Antikoagulanz aPTT PTZ Thromboplastinzeit (Quick)

Prüfmaterial (Matrix)
Citratplasma Citratplasma Citratplasma Citratplasma Citratplasma Citratplasma

Prüftechnik
Koagulometrie Koagulometrie Koagulometrie Koagulometrie Koagulometrie Koagulometrie

Anweisung/Version
SOP-0133 / V 10.0 SOP-0133 / V 10.0 SOP-0101 / V 13.0 SOP-0133 / V 10.0 SOP-0133 / V 10.0 SOP-0133 / V 10.0

Gerät
Siemens BCS-XP Siemens BCS-XP Roche Coasys Plus C Siemens BCS-XP Siemens BCS- XP Siemens BCS-XP

Prüfart: Spektrometrie (Fluoreszenzspektrometrie)

Analyt (Messgröße) Thrombin Generierungs Test

Prüfmaterial (Matrix)
Citratplasma

Prüftechnik Fluorometrie

Anweisung/Version

Gerät

SOP-0118 / V 9.0; WP- Stago Thrombinoscop 0132 / V5.0

Prüfart: Ligandenassays*

Analyt (Messgröße)
Androstendion Anti-Tissue Transglutaminase AK Beta-HCG BNP-pro-NT Bone AP

Prüfmaterial (Matrix)
Serum Serum
Serum Serum Serum

Calcitonin Calprotectin

Serum Stuhl

Cortisol

Serum

Prüftechnik Immunoassay (ECLIA) Immunoassay (EIA)
Immunoassay (ECLIA) Immunoassay (ECLIA) Immunoassay (EIA)
Immunoassay (ECLIA) Immunoassay (EIA)
Immunoassay (ECLIA)

Anweisung/Version
SOP-0139 / V 8.0 SOP-0018 / V 12.0; SOP-0022 / V 12.0 SOP-0139 / V 8.0 SOP-0139 / V 8.0 SOP-0018 / V 12.0; SOP-0022 / V 12.0
SOP-0139 / V 8.0 SOP-0018 / V 12.0; SOP-0022 / V 12.0 SOP-0139 / V 8.0

Gerät
Roche Cobas 6000 e601 Tecan SLT-Reader (Manueller Immunoassay) Roche Cobas 6000 e601 Roche Cobas 6000 e601 Tecan SLT-Reader (Manueller Immunoassay)
Roche Cobas 6000 e601 Tecan SLT-Reader (Manueller Immunoassay) Roche Cobas 6000 e601

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Analyt (Messgröße)
D-Dimer
DHEA-SO4 Estradiol Ferritin Folsäure FSH hGH IGF-1 IGFBP-3 Insulin LH Osteocalcin P1NP Progesteron Prolaktin Prothrombin-Fragment 1+2
PSA (total) SHBG T3 frei T3 total T4 frei T4 total Testosteron Troponin I (hs) Troponin T TSH Vitamin B12

Prüfmaterial (Matrix)
Citratplasma
Serum Serum Serum Serum Serum Serum Serum Serum Serum Serum Serum Serum Serum Serum Citratplasma
Serum Serum Serum Serum Serum Serum Serum Serum Serum Serum Serum

Prüftechnik
Immunoassay (EIA)
Immunoassay (ECLIA) Immunoassay (ECLIA) Immunoassay (ECLIA) Immunoassay (ECLIA) Immunoassay (ECLIA) Immunoassay (ECLIA) Immunoassay (CLIA) Immunoassay (CLIA) Immunoassay (ECLIA) Immunoassay (ECLIA) Immunoassay (ECLIA) Immunoassay (ECLIA) Immunoassay (ECLIA) Immunoassay (ECLIA) Immunoassay (EIA)
Immunoassay (ECLIA) Immunoassay (ECLIA) Immunoassay (ECLIA) Immunoassay (ECLIA) Immunoassay (ECLIA) Immunoassay (ECLIA) Immunoassay (ECLIA) Immunoassay (ELFA) Immunoassay (ECLIA) Immunoassay (ECLIA) Immunoassay (ECLIA)

Anweisung/Version
SOP-0018 / V 12.0; SOP-0022 / V 12.0
SOP-0139 / V 8.0 SOP-0139 / V 8.0 SOP-0139 / V 8.0 SOP-0139 / V 8.0 SOP-0139 / V 8.0 SOP-0139 / V 8.0 SOP-0123 / V 13.0 SOP-0123 / V 13.0 SOP-0139 / V 8.0 SOP-0139 / V 8.0 SOP-0139 / V 8.0 SOP-0139 / V 8.0 SOP-0139 / V 8.0 SOP-0139 / V 8.0 SOP-0018 / V 12.0; SOP-0022 / V 12.0
SOP-0139 / V 8.0 SOP-0139 / V 8.0 SOP-0139 / V 8.0 SOP-0139 / V 8.0 SOP-0139 / V 8.0 SOP-0139 / V 8.0 SOP-0139 / V 8.0 SOP-0194 / V 2.0 SOP-0139 / V 8.0 SOP-0139 / V 8.0 SOP-0139 / V 8.0

Gerät
Tecan SLT-Reader (Manueller Immunoassay)
Roche Cobas 6000 e601 Roche Cobas 6000 e601 Roche Cobas 6000 e601 Roche Cobas 6000 e601 Roche Cobas 6000 e601 Roche Cobas 6000 e601 IDS-iSYS IDS-iSYS Roche Cobas 6000 e601 Roche Cobas 6000 e601 Roche Cobas 6000 e601 Roche Cobas 6000 e601 Roche Cobas 6000 e601 Roche Cobas 6000 e601 Tecan SLT-Reader (Manueller Immunoassay)
Roche Cobas 6000 e601 Roche Cobas 6000 e601 Roche Cobas 6000 e601 Roche Cobas 6000 e601 Roche Cobas 6000 e601 Roche Cobas 6000 e601 Roche Cobas 6000 e601 Biomerieux Vidas 3 Roche Cobas 6000 e601 Roche Cobas 6000 e601 Roche Cobas 6000 e601

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Analyt (Messgröße) Vitamin-D 25-OH

Prüfmaterial (Matrix)
Serum

Prüftechnik

Anweisung/Version

Gerät

Immunoassay (ECLIA) SOP-0139 / V 8.0

Roche Cobas 6000 e601

Prüfart: Mikroskopie*

Analyt (Messgröße)
Differentialblutbild, manuell Urinsediment (inkl. Bakterien, Epithelien und Zylinder)

Prüfmaterial (Matrix)
EDTA-Blut
Urin

Prüftechnik
Mikroskopie Mikroskopie

Anweisung/Version
SOP-0017 / V 13.0 SO-0163 / V 6.0; WP0057 / V 10.0

Gerät
Mikroskop Mikroskop

Prüfgebiet: Immunologie

Prüfart: Mikroskopie *
Analyt (Messgröße) Zirkulierende Tumorzellen

Prüfmaterial (Matrix)
EDTA-Blut

Prüftechnik

Anweisung/Version

Gerät

Fluoreszenzmikroskop SOP-0149 / V 6.0

CellSearch

Prüfart: Durchflusszytometrie*

Analyt (Messgröße)
T-Lymphozyten Subpopulation (CD3, CD4, CD8)

Prüfmaterial (Matrix)
EDTA-Blut

Lymphozyten-Differenzierung EDTA-Blut (CD3, CD4, CD8, CD16/56, CD19, CD45)

Prüftechnik Durchflusszytometrie
Durchflusszytometrie

Anweisung/Version
SOP-0120 / V 11.0; WP-0162 / V 3.0
SOP-0120 / V 11.0; WP-0162 / V 3.0

Gerät BD FACSCanto II
BD FACSCanto II

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Prüfart: Ligandenassays**

Analyt (Messgröße) Anti-CCP C3a
C5a
IgE Interferon

Prüfmaterial (Matrix)
Serum EDTA plasma
EDTA plasma
Serum Serum

Prüftechnik Immunoassay (ECLIA) Immunoassay (EIA)
Immunoassay (EIA)
Immunoassay (ECLIA) Immunoassay (ECLIA)

Interleukin 2

Serum

Immunoassay (ECLIA)

Interleukin 6

Serum

Immunoassay (ECLIA)

Interleukin 8

Serum

Immunoassay (ECLIA)

Interleukin 10

Serum

Immunoassay (ECLIA)

TB-induzierte -IFN-Freisetzung Plasma (QFT-Plus

(Quantiferon-TB Gold)

Entnahmeröhrchen)

TNF

Serum

Immunoassay (EIA) Immunoassay (ECLIA)

(x) not CE-marked assay but also not modified or in-house developed test

Anweisung/Version

Gerät

SOP-0139 / V 8.0
SOP-0018 / V 12.0; SOP-0022 / V 12.0 SOP-0018 / V 12.0; SOP-0022 / V 12.0 SOP-0139 / V 8.0
SOP-0018 / V 12.0; SOP-0157 / V 6.0; WP0158 / V 4.0 SOP-0018 / V 12.0; SOP-0157 / V 6.0; WP0158 / V 4.0 SOP-0018 / V 12.0; SOP-0157 / V 6.0; WP0158 / V 4.0 SOP-0018 / V 12.0; SOP-0157 / V 6.0; WP0158 / V 4.0 SOP-0018 / V 12.0; SOP-0157 / V 6.0; WP0158 / V 4.0 SOP-0018 / V 12.0; SOP-0022 / V 12.0

Roche Cobas 6000 e601 Tecan SLT-Reader (Manueller Immunoassay) Tecan SLT- Reader (Manueller Immunoassay) Roche Cobas 6000 e601 Meso QuickPlex SQ 120
Meso QuickPlex SQ 120
Meso QuickPlex SQ 120
Meso QuickPlex SQ 120
Meso QuickPlex SQ 120
Tecan SLT-Reader (Manueller Immunoassay)

SOP-0018 / V 12.0;

Meso QuickPlex SQ 120

SOP-0157 / V 6.0; WP-

0158 / V 4.0

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Analyt (Messgröße)
C3c-Komplement IgA IgG IgM

Prüfmaterial (Matrix)
EDTA plasma Serum Serum Serum

Prüftechnik
Immunnephelometrie Immunnephelometrie Immunnephelometrie Immunnephelometrie

Anweisung/Version
SOP-0184 / V 4.0 SOP-0184 / V 4.0 SOP-0184 / V 4.0 SOP-0184 / V 4.0

Gerät
Siemens Atellica NEPH 630 Siemens Atellica NEPH 630 Siemens Atellica NEPH 630 Siemens Atellica NEPH 630

Prüfgebiet: Mikrobiologie

Prüfart: Ligandenassays* Analyt (Messgröße)
Haemophilus Influenza IgG Tetanus IgG

Prüfmaterial (Matrix)
Serum
Serum

Prüftechnik Immunoassay (EIA)
Immunoassay (EIA)

Anweisung/Version
SOP-0018 / V 12.0; SOP-0022 / V 12.0 SOP-0018 / V 12.0; SOP-0022 / V 12.0

Gerät
Tecan SLT-Reader (Manueller Immunoassay) Tecan SLT-Reader (Manueller Immunoassay)

Prüfgebiet: Virologie

Prüfart: Ligandenassays*
Analyt (Messgröße) CMV IgG
HAV-Ak HAV-Ak (IgM)

Prüfmaterial (Matrix)
Serum
Serum Serum

Prüftechnik Immunoassay (EIA)
Immunoassay (ECLIA) Immunoassay (ECLIA)

Anweisung/Version
SOP-0018 / V 12.0; SOP-0022 / V 12.0 SOP-0139 / V 8.0 SOP-0139 / V 8.0

Gerät
Tecan SLT-Reader (Manueller Immunoassay) Roche Cobas 6000 e601 Roche Cobas 6000 e601

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Analyt (Messgröße)
HB-c-Ak HB-c-Ak (IgM) HB-s-Ag HB-s-Ak HCV-Ak HIV-AG/Ak SARS-CoV-2-Ak Masern IgG

Prüfmaterial (Matrix)
Serum Serum Serum Serum Serum Serum Serum Serum

Prüftechnik
Immunoassay (ECLIA) Immunoassay (ECLIA) Immunoassay (ECLIA) Immunoassay (ECLIA) Immunoassay (ECLIA) Immunoassay (ECLIA) Immunoassay (ECLIA) Immunoassay (EIA)

Anweisung/Version
SOP-0139 / V 8.0 SOP-0139 / V 8.0 SOP-0139 / V 8.0 SOP-0139 / V 8.0 SOP-0139 / V 8.0 SOP-0139 / V 8.0 SOP-0139 / V 8.0 SOP-0018 / V 12.0; SOP-0022 / V 12.0

Gerät
Roche Cobas 6000 e601 Roche Cobas 6000 e601 Roche Cobas 6000 e601 Roche Cobas 6000 e601 Roche Cobas 6000 e601 Roche Cobas 6000 e601 Roche Cobas 6000 e601 Tecan SLT-Reader (Manueller Immunoassay)

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