FDA UDI
In Commercial Distribution
🇺🇸 United States
Axis-Shield Active-B12 (Holotranscobalamin) EIA
DI: 05055845400046
·
Model: FMABT100
·
AXIS-SHIELD DIAGNOSTICS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Axis-Shield Active-B12 (Holotranscobalamin) EIA
- Primary DI
- 05055845400046
- Version / Model
- FMABT100
- Catalog Number
- FMABT100
- Company Name
- AXIS-SHIELD DIAGNOSTICS LIMITED
- Labeler DUNS
- 229062427
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-02
- Public Version
- 4
- Public Version Date
- 2022-08-05
- Public Version Status
- Update
- Public Device Record Key
- 63f8bc2a-341b-4295-9462-346baec81c21
Device Description
The Axis-Shield Active-B12 (Holotranscobalamin) assay is an enzyme-immunoassay (EIA) for the quantitative determination of holotranscobalamin (HoloTC) in human serum. HoloTC (vitamin B12 bound to transcobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency.
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 |
|---|---|---|---|---|
| CDD | Radioassay, Vitamin B12 | Clinical Chemistry | 862.1810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54458 | Vitamin B12 IVD, reagent | A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of vitamin B12, also known as cobalamin, in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055845400046 | GS1 |
Customer Contacts
- Phone
- +441382422000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121946 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius