FDA UDI
In Commercial Distribution
🇺🇸 United States
CRYOcheck Factor VIII Chromogenic
DI: 00843876000602
·
Model: CCCF08
·
Precision Biologic Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CRYOcheck Factor VIII Chromogenic
- Primary DI
- 00843876000602
- Version / Model
- CCCF08
- Catalog Number
- CCCF08
- Company Name
- Precision Biologic Inc
- Labeler DUNS
- 244713368
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-25
- Public Version
- 1
- Public Version Date
- 2025-12-03
- Public Version Status
- New
- Public Device Record Key
- d6fc3f88-69c3-4db5-a5ea-00acff312426
Device Description
CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determination of factor VIII activity in 3.2% citrated human plasma. 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
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | Hematology | 864.7290 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56022 | Coagulation factor VIII IVD, kit, chromogenic | A collection of reagents and other associated materials intended to be used for the quantitative measurement of coagulation factor VIII in a clinical specimen, using a chromogenic method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00843876000602 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K251440 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – -70 Degrees Celsius