FDA UDI
In Commercial Distribution
🇺🇸 United States
Anti-K
DI: 00858400005008
·
Model: 510200
·
AMERICAN NATIONAL RED CROSS
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Anti-K
- Primary DI
- 00858400005008
- Version / Model
- 510200
- Company Name
- AMERICAN NATIONAL RED CROSS
- Labeler DUNS
- 003255213
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-12
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 537e90c4-0b53-40bb-80bf-614964320d52
Device Description
Blood Grouping Reagent
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52593 | Anti-K (KEL001) red blood cell grouping IVD, antibody | One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used in testing a clinical specimen for K [KEL001] red blood cell antigens from the Kell system, using an agglutination method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858400005008 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 8 Degrees Celsius