FDA UDI
In Commercial Distribution
🇺🇸 United States
ImmunoWELL Thyroglobulin IgG Quantitative Test
DI: 00613745030302
·
Model: 800-3030
·
Genbio
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ImmunoWELL Thyroglobulin IgG Quantitative Test
- Primary DI
- 00613745030302
- Version / Model
- 800-3030
- Catalog Number
- 3030
- Company Name
- Genbio
- Labeler DUNS
- 940425333
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 1d85cebd-2c7a-4e49-9920-aae352617e29
Device Description
The ImmunoWELL Thyroglobulin IgG Quantitative Test is a quantitative enzyme immunoassay (EIA) for screening and detection of autoantibodies against human thyroglobulin in serum and is used as an aid in the diagnosis of thyroid disorders.
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 |
|---|---|---|---|---|
| JNL | Immunochemical, Thyroglobulin Autoantibody | Immunology | 866.5870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55196 | Thyroglobulin antibody 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 thyroglobulin in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00613745030302 | GS1 |
Customer Contacts
- Phone
- 858-592-9300
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K905485 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 96 tests |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius