FDA UDI
In Commercial Distribution
🇺🇸 United States
GAD65 Ab ELISA
DI: 04048474040876
·
Model: EIA-4087
·
DRG Instruments Gesellschaft mit beschränkter Haftung
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- GAD65 Ab ELISA
- Primary DI
- 04048474040876
- Version / Model
- EIA-4087
- Catalog Number
- EIA-4087
- Company Name
- DRG Instruments Gesellschaft mit beschränkter Haftung
- Labeler DUNS
- 317134468
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-02
- Public Version
- 1
- Public Version Date
- 2024-12-10
- Public Version Status
- New
- Public Device Record Key
- 813d4b82-48de-421e-bacb-b382ffbd90a7
Device Description
The GAD65 Autoantibody (GAD Ab) ELISA kit is intended for use by professional persons only, for the quantitative determination of GAD Ab in human serum.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 54916 | Glutamic acid decarboxylase antibody (anti-GAD) IVD, kit, enzyme immunoassay (EIA) | 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 an enzyme immunoassay (EIA) 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 | 04048474040876 | GS1 |
Customer Contacts
- Phone
- 973-564-7555
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius