CRYOcheck Factor VIII Deficient Plasma with VWF
Basic Information
- Brand Name
- CRYOcheck Factor VIII Deficient Plasma with VWF
- Primary DI
- 00843876000589
- Version / Model
- FDP08VWF
- Catalog Number
- FDP08VWF-15
- Company Name
- Precision Biologic Inc
- Labeler DUNS
- 244713368
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2023-09-25
- Public Version
- 1
- Public Version Date
- 2023-10-03
- Public Version Status
- New
- Public Device Record Key
- 3e461d29-ccc6-40d9-ae5d-9b137d9d1f30
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
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GJT | Plasma, Coagulation Factor Deficient | Hematology | 864.7290 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56025 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00843876010564 | GS1 | ||||
| Primary | 00843876000589 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222831 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -80 – -40 Degrees Celsius