CRYOcheck Factor VIII Deficient Plasma with VWF
- Primary DI
- 00843876000589
- Brand
- CRYOcheck Factor VIII Deficient Plasma with VWF
- Company
- Precision Biologic Inc
- Model
- FDP08VWF
- Catalog number
- FDP08VWF-15
- Device description
- CRYOcheck Factor VIII Deficient Plasma with VWF is for clinical laboratory use as a deficient substrate in the quantitative determination of Factor VIII activity in 3.2% sodium citrated human plasma based on the activated partial thromboplastin time (APTT) assay. It is intended to be used in identifying Factor VIII deficiency and as an aid in the management of hemophilia A in individuals aged 2 years and older. For in vitro diagnostic use. CRYOcheck Factor VIII Deficient Plasma with VWF is normal human citrated plasma which has been immunodepleted of factor VIII and which contains normal levels of von Willebrand Factor (VWF), buffered with HEPES. Factor VIII has been assayed at less than 1% of normal antigen and activity levels while VWF antigen and activity levels are >50%. Device is provided frozen as 25 vials of 1.0 mL
- Published
- 2023-09-25
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Product Codes#
| Code | Name |
|---|---|
| GJT | Plasma, Coagulation Factor Deficient |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| GJT | Plasma, Coagulation Factor Deficient | Hematology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K222831 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00843876000589 | Primary | GS1 | 0 | |
| 00843876010564 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00843876000589 | 00843876000589 | 843876000589 | 0843876000589 |
| 00843876010564 | 00843876010564 | 843876010564 | 0843876010564 |
GMDN Terms#
| Term | Definition |
|---|---|
| Coagulation factor VIII IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of coagulation factor VIII in a clinical specimen. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | -80 Degrees Celsius | -40 Degrees Celsius |
Regulatory Flags#
- DUNS number
- 244713368
- Device count
- 25
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00843876000015 | CRYOcheck™ Pooled Normal Plasma | CCN-10 | 2016-09-23 | |
| 00843876000022 | CRYOcheck™ Pooled Normal Plasma | CCN-15 | 2016-09-23 | |
| 00843876000039 | CRYOcheck™ Pooled Normal Plasma | CCN10-10 | 2016-09-23 | |
| 00843876000046 | CRYOcheck™ Pooled Normal Plasma | CCN-40 | 2016-09-23 | |
| 00843876000053 | CRYOcheck™ Reference Control Normal | RCN-05 | 2016-09-23 | |
| 00843876000060 | CRYOcheck™ Reference Control Normal | RCN-10 | 2016-09-23 | |
| 00843876000077 | CRYOcheck™ Abnormal 1 Reference Control | ARP1-05 | 2016-09-23 | |
| 00843876000084 | CRYOcheck™ Abnormal 1 Reference Control | ARP1-10 | 2016-09-23 | |
| 00843876000091 | CRYOcheck™ Abnormal 2 Reference Control | ARP2-10 | 2016-09-23 | |
| 00843876000190 | CRYOcheck™ Normal Reference Plasma | CCNRP-05 | 2016-09-23 | |
| 00843876000206 | CRYOcheck™ Normal Reference Plasma | CCNRP-10 | 2016-09-23 | |
| 00843876000213 | CRYOcheck™ Factor II Deficient Plasma | FDP02-10 | 2016-09-23 | |
| 00843876000220 | CRYOcheck™ Factor II Deficient Plasma | FDP02-15 | 2016-09-23 | |
| 00843876000237 | CRYOcheck™ Factor V Deficient Plasma | FDP05-10 | 2016-09-23 | |
| 00843876000244 | CRYOcheck™ Factor V Deficient Plasma | FDP05-15 | 2016-09-23 | |
| 00843876000251 | CRYOcheck™ Factor VII Deficient Plasma | FDP07-10 | 2016-09-23 | |
| 00843876000268 | CRYOcheck™ Factor VII Deficient Plasma | FDP07-15 | 2016-09-23 | |
| 00843876000275 | CRYOcheck™ Factor VIII Deficient Plasma | FDP08-10 | 2016-09-23 | |
| 00843876000282 | CRYOcheck™ Factor VIII Deficient Plasma | FDP08-15 | 2016-09-23 | |
| 00843876000299 | CRYOcheck™ Factor VIII Deficient Plasma | FDP08-40 | 2016-09-23 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00630414639598 | Coagulation Factor X Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | GJT | 2024-03-25 |
| 00630414639604 | Coagulation Factor XI Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | GJT | 2024-03-25 |
| 00630414640587 | Coagulation Factor IX Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | GJT | 2024-03-25 |
| 00630414640679 | Coagulation Factor XII Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | GJT | 2024-03-25 |
| 00630414640686 | Coagulation Factor II Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | GJT | 2024-03-25 |
| 00630414640761 | Coagulation Factor VIII Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | GJT | 2024-03-25 |
| 00630414640792 | Coagulation Factor VII Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | GJT | 2024-03-25 |
| 00842768018817 | Coagulation Factor X Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | GJT | 2024-03-25 |
| 00842768018879 | Coagulation Factor XI Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | GJT | 2024-03-25 |
| 00842768018824 | Coagulation Factor IX Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | GJT | 2024-03-25 |
| 00842768018862 | Coagulation Factor XII Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | GJT | 2024-03-25 |
| 00842768018855 | Coagulation Factor II Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | GJT | 2024-03-25 |
| 00842768018831 | Coagulation Factor VIII Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | GJT | 2024-03-25 |
| 00842768018848 | Coagulation Factor VII Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | GJT | 2024-03-25 |
| 00630414640754 | Coagulation Factor V Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | GJT | 2024-02-19 |
| 00842768018886 | Coagulation Factor V Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | GJT | 2024-02-19 |
| 00843876000572 | CRYOcheck Factor VIII Deficient Plasma with VWF | Precision Biologic Inc | GJT | 2023-09-25 |
| 00843876010557 | CRYOcheck Factor VIII Deficient Plasma with VWF | Precision Biologic Inc | GJT | 2023-09-25 |
| 00843876010564 | CRYOcheck Factor VIII Deficient Plasma with VWF | Precision Biologic Inc | GJT | 2023-09-25 |
| 00815696021310 | George King Factor VIII Deficient Plasma | GEORGE KING BIO-MEDICAL, INC | GJT | 2022-03-03 |
| 00815696021211 | George King Factor V Deficient Plasma | GEORGE KING BIO-MEDICAL, INC | GJT | 2020-02-27 |
| 00815696021075 | George King FVII Deficient Plasma | GEORGE KING BIO-MEDICAL, INC | GJT | 2017-06-26 |
| 00815696021082 | George King FVII Deficient Plasma | GEORGE KING BIO-MEDICAL, INC | GJT | 2017-06-26 |
| 00815696021037 | George King Congential Factor Deficiency Convenience Kit | GEORGE KING BIO-MEDICAL, INC | GJT | 2017-03-20 |
| 10859394006153 | NoFact VIII | R 2 DIAGNOSTICS, INC. | GJT | 2016-11-15 |
| 10859394006160 | NoFact IX | R 2 DIAGNOSTICS, INC. | GJT | 2016-11-15 |
| 00842768009525 | Coagulation Factor V Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | GJT | 2016-09-24 |
| 00842768009976 | Coagulation Factor XI Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | GJT | 2016-09-24 |
| 00842768009990 | Coagulation Factor XII Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | GJT | 2016-09-24 |
| 00842768010156 | Coagulation Factor II Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | GJT | 2016-09-24 |