FDA UDI
In Commercial Distribution
🇺🇸 United States
CRYOcheck™ FVIII Inhibitor Kit
DI: 00843876000503
·
Model: CCIK08
·
Precision Biologic Inc
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CRYOcheck™ FVIII Inhibitor Kit
- Primary DI
- 00843876000503
- Version / Model
- CCIK08
- Company Name
- Precision Biologic Inc
- Labeler DUNS
- 244713368
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-25
- Public Version
- 1
- Public Version Date
- 2019-04-02
- Public Version Status
- New
- Public Device Record Key
- 9b813cec-1d47-4b0a-892c-f20a282ff9bf
Device Description
The CRYOcheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction with a factor VIII activity assay to enable performance of a modified Nijmegen-Bethesda assay using 3.2% citrated human plasma. It enables the determination of a functional FVIII inhibitor titer to aid in the clinical management of congenital hemophilia A in individuals aged 2 years and older.
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 |
|---|---|---|---|---|
| GGN | Plasma, Coagulation Control | Hematology | 864.5425 | 2 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | Hematology | 864.7290 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56171 | Coagulation factor VIII inhibitor IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of coagulation factor VIII inhibitor in a clinical specimen. | No | Active |
| 56172 | Coagulation factor VIII inhibitor 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 qualitative and/or quantitative detection of coagulation factor VIII inhibitor in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00843876000503 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183440 | 000 |