FDA UDI
In Commercial Distribution
🇺🇸 United States
VisuLize Factor FIX Antigen Kit
DI: 10629009020009
·
Model: FIX-AG
·
Affinity Biologicals Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- VisuLize Factor FIX Antigen Kit
- Primary DI
- 10629009020009
- Version / Model
- FIX-AG
- Company Name
- Affinity Biologicals Inc
- Labeler DUNS
- 249373515
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-28
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 65249ea9-2e63-4400-b7de-3ecfda6d7290
Device Description
96 Test enzyme immunoassay kit for the determination of FIX Antigen
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| 62188 | Coagulation factor IX IVD, kit, enzyme immunoassay (EIA) | 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 an enzyme immunoassay (EIA) 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 | 10629009020009 | GS1 | ||||
| Previous | 16290090020007 | GS1 |
Customer Contacts
- Phone
- 1-800-903-6020
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051054 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze.
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius