COAGULATION CALIBRATOR (COAG CAL)
- Primary DI
- 05055273208405
- Brand
- COAGULATION CALIBRATOR (COAG CAL)
- Company
- RANDOX LABORATORIES LIMITED
- Model
- CG5037
- Published
- 2019-06-03
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| JIT | Calibrator, Secondary |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| JIT | Calibrator, Secondary | Clinical Chemistry | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 05055273208405 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 05055273208405 | 05055273208405 | 5055273208405 |
GMDN Terms
| Term | Definition |
|---|
| Multiple coagulation factor IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen. |
Regulatory Flags
- DUNS number
- 227530649
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 05055273210125 | LIQUID IMMUNOASSAY CONTROL - LEVEL 3 (IA CONTROL 3) | LIA5144 | LIA5144 | 2025-03-24 |
| 05055273219814 | PTH CONTROL LEVEL 1 (PTH CONTROL 1) | PTH10608 | PTH10608 | 2025-03-24 |
| 05055273219821 | PTH CONTROL LEVEL 2 (PTH CONTROL 2) | PTH10609 | PTH10609 | 2025-03-24 |
| 05055273219838 | PTH CONTROL LEVEL 3 (PTH CONTROL 3) | PTH10610 | PTH10610 | 2025-03-24 |
| 05055273219043 | LIQUID CARDIAC CONTROL 1 | CQ10534 | CQ10534 | 2025-03-21 |
| 05055273219050 | LIQUID CARDIAC CONTROL 2 | CQ10535 | CQ10535 | 2025-03-21 |
| 05055273219067 | LIQUID CARDIAC CONTROL 3 | CQ10536 | CQ10536 | 2025-03-21 |
| 05055273219128 | LIQUID CARDIAC CONTROL LEVEL 1 (LIQUID CARDIAC CONTROL 1) | CQ10616 | CQ10616 | 2025-03-21 |
| 05055273219135 | LIQUID CARDIAC CONTROL LEVEL 2 (LIQUID CARDIAC CONTROL 2) | CQ10617 | CQ10617 | 2025-03-21 |
| 05055273219142 | LIQUID CARDIAC CONTROL LEVEL 3 (LIQUID CARDIAC CONTROL 3) | CQ10618 | CQ10618 | 2025-03-21 |
| 05055273219159 | Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1) | LAL10565 | LAL10565 | 2025-03-21 |
| 05055273219166 | Assayed Liquid Chemistry Control Level 2 (ASY LIQ CHEM CONTROL 2) | LAN10566 | | 2025-03-21 |
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