FDA UDI
In Commercial Distribution
🇺🇸 United States
KRONUS GLUTAMIC ACID DECARBOXYLASE RIA ANTIBODY KIT
DI: B126KR67100
·
Model: KR6710
·
KRONUS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KRONUS GLUTAMIC ACID DECARBOXYLASE RIA ANTIBODY KIT
- Primary DI
- B126KR67100
- Version / Model
- KR6710
- Catalog Number
- KR6710
- Company Name
- KRONUS, INC.
- Labeler DUNS
- 181070814
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 67011a56-5c64-4e2b-910a-c43c9ced7cea
Device Description
An enzyme linked immunosorbent assay for the semi-quantitative determination of glutamic acid decarboxylase (GAD) antibody in human serum.
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 |
|---|---|---|---|---|
| NWG | Autoantibodies, Glutamic Acid Decarboxylase (Gad) | Immunology | 866.5660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54917 | Glutamic acid decarboxylase antibody (anti-GAD) IVD, kit, radioimmunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to glutamic acid decarboxylase (anti-GAD) in a clinical specimen, using a radioimmunoassay method. It is typically used as a predictive marker for the progression of autoimmune diabetes and the eventual onset of insulin-dependent diabetes mellitus. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B126KR67100 | HIBCC |
Customer Contacts
- Phone
- 800-457-6687
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051061 | 000 |