DRG CTL-5951 Estrone-3-Sulfate (equine) Control Owner’s Manual
- June 16, 2024
- DRG
Table of Contents
DRG CTL-5951 Estrone-3-Sulfate (equine) Control
Product Information
Specifications
- Product Name: Estrone-3-Sulfate (equine) Control
- Product Code: CTL-5951
- Manufacturer: DRG International, Inc.
- Storage: Store in aliquots after reconstitution
- Shelf Life: 6 months after reconstitution or until the expiration date
Application
The Estrone-3-Sulfate (equine) Control CTL-5951 is designed to be used for internal quality control according to the respective instructions for use of the DRG Estrone-3-Sulfate (equine) ELISA (EIA-5223).
Target Values
The target values provided below are intended as guidelines only. Each laboratory should develop its own expected values due to inter-laboratory variations
| Parameter | Control 1 | Control 2 |
|---|---|---|
| Estrone-3-Sulfate (ng/mL) | 82 | 297 |
| Target Range (ng/mL) | 53-111 | 193-401 |
Symbols Used
Here are some symbols used in the product manual:
| Symbol | English | Deutsch | Italiano |
|---|---|---|---|
| European Conformity | European Conformity | Komponente | Conformidad europea |
| Consult instructions for use | Consult instructions for use | Gebrauchsanweisung | |
| beachten | Consulte las instrucciones de uso | ||
| In vitro diagnostic medical device | In vitro diagnostic medical device | In- | |
| vitro-Diagnostikum | Diagnostic in vitro | ||
| Catalogue number | Catalogue number | Katalognummer | No. di Cat. |
| Batch code | Batch code | Chargen-bezeichnung | Lotto no |
| Contains sufficient for tests | Contains sufficient for tests | Contenuto | |
| sufficiente per n saggi | Contenido suficiente para ensayos | ||
| Temperature limit | Temperature limit | Temperaturgrenzwerte | Temperatura di |
conservazione
Use-by date| Use-by date| Verwendbar bis| Data di scadenza
Manufacturer| Manufacturer| Hersteller| Fabbricante
Distributor| Distributor| Vertriebspartner| Distributore
Date of manufacture| Date of manufacture| Herstellungsdatum| Data di
produzione
Biological risks| Biological risks| Biologische Risiken|
Caution| Caution| Achtung| Attenzione
Unique device Identifier| Unique device Identifier| eindeutige
Produktidentifizierung| Identificativo unico del dispositivo
Product Usage Instructions
Materials Supplied, Storage, and Stability
The Estrone-3-sulfate control CTL-5951 is supplied as a lyophilized preparation in 1 set. Before use, each vial should be reconstituted with the provided solvent. The reconstitution process should be done approximately 30 minutes before use. After reconstitution, any unused portion should be stored in aliquots. The product has a shelf life of 6 months after reconstitution or until the expiration date.
Application
The Estrone-3-Sulfate (equine) Control CTL-5951 can be used forinternal quality control according to the respective instructions for use of the DRG Estrone-3-Sulfate (equine) ELISA (EIA-5223).
Target Values
The provided target values for the Estrone-3-Sulfate control CTL-5951 are as follows:
- Control 1: Mean – 82 ng/mL, Target Range – 53-111 ng/mL
- Control 2: Mean – 297 ng/mL, Target Range – 193-401 ng/mL
Symbols Used
Here are some symbols used in the product manual:
| Symbol | English | Deutsch | Italiano |
|---|---|---|---|
| European Conformity | European Conformity | Komponente | Conformidad europea |
| Consult instructions for use | Consult instructions for use | Gebrauchsanweisung | |
| beachten | Consulte las instrucciones de uso | ||
| In vitro diagnostic medical device | In vitro diagnostic medical device | In- | |
| vitro-Diagnostikum | Diagnostic in vitro | ||
| Catalogue number | Catalogue number | Katalognummer | No. di Cat. |
| Batch code | Batch code | Chargen-bezeichnung | Lotto no |
| Contains sufficient for tests | Contains sufficient for tests | Contenuto | |
| sufficiente per n saggi | Contenido suficiente para ensayos | ||
| Temperature limit | Temperature limit | Temperaturgrenzwerte | Temperatura di |
conservazione
Use-by date| Use-by date| Verwendbar bis| Data di scadenza
Manufacturer| Manufacturer| Hersteller| Fabbricante
Distributor| Distributor| Vertriebspartner| Distributore
Date of manufacture| Date of manufacture| Herstellungsdatum| Data di
produzione
Biological risks| Biological risks| Biologische Risiken|
Caution| Caution| Achtung| Attenzione
Unique device Identifier| Unique device Identifier| eindeutige
Produktidentifizierung| Identificativo unico del dispositivo
Please use only the valid version of the Instructions for Use provided with the kit.
MATERIALS SUPPLIED, STORAGE AND STABILITY
Components| Content| Preparation| Storage at| Shelf
life
---|---|---|---|---
Estrone-3-sulfate control 1 & 2:
CONTROL 1
CONTROL 2
Two levels of Estrone-3-sulfate in equine serum
| ****
1 Set
2 vials à 1 mL
| lyophilized;
reconstitute each vial with
1 mL dist. H2O
30 minutes before use
| 2 °C – 8 °C;
after reconstitution store in aliquots
at -20 °C
| ****
6 months after reconstitution or until the expiration date
APPLICATION
According to the respective instructions for use of the DRG Estrone-3-Sulfate (equine) ELISA (EIA-5223) the control can be used for internal quality control. The procedure calls for 20 µL sample volume per test.
TARGET VALUES
The values provided here are intended as guidelines only. Because of many sources of inter-laboratory variations each laboratory should develop its own expected values.
| Parameter | Control | Mean (ng/mL) | Target Range (ng/mL) |
|---|
Estrone-3-Sulfate
| Control 1| 82| 53-111
Control 2| 297| 193-401
SYMBOLS USED
-
DRG Instruments GmbH, Germany Frauenbergstraße 18, 35039 Marburg
-
Phone: +49 (0)6421-1700 0,
-
Fax: +49 (0)6421-1700 50
-
Website: www.drg-diagnostics.de
-
E-mail: drg@drg-diagnostics.de
-
DRG International, Inc., USA 841 Mountain Ave., Springfield, NJ 07081
-
Phone: 973-564-7555,
-
Fax: 973-564-7556
-
Website: www.drg-international.com
E-mail: corp@drg-international.com