FDA UDI
In Commercial Distribution
🇺🇸 United States
CRYOcheck Chromogenic Factor IX
DI: 00843876000565
·
Model: CCCF09
·
Precision Biologic Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CRYOcheck Chromogenic Factor IX
- Primary DI
- 00843876000565
- Version / Model
- CCCF09
- Catalog Number
- CCCF09
- Company Name
- Precision Biologic Inc
- Labeler DUNS
- 244713368
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-06
- Public Version
- 1
- Public Version Date
- 2023-01-16
- Public Version Status
- New
- Public Device Record Key
- 8c905a33-2dc0-4dd4-89f3-f316c00c4f65
Device Description
CRYOcheck Chromogenic Factor IX is for clinical laboratory use in the quantitative determination of factor IX activity in 3.2% citrated human plasma. It is intended to be used in identifying factor IX deficiency and as an aid in the management of hemophilia B 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 |
|---|---|---|---|---|
| 56249 | Coagulation factor IX IVD, kit, chromogenic | A collection of reagents and other associated materials intended to be used for the quantitative detection of coagulation factor IX in a clinical specimen, using a chromogenic method. Factor IX deficiency may result in a hereditary bleeding disorder known as haemophilia B or Christmas disease. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00843876000565 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K214002 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – -70 Degrees Celsius