FDA UDI
In Commercial Distribution
🇺🇸 United States
Anti-Thyroglobulin (Anti-Tg) ELISA
DI: 00840239041104
·
Model: EIA-4110
·
DRG International Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Anti-Thyroglobulin (Anti-Tg) ELISA
- Primary DI
- 00840239041104
- Version / Model
- EIA-4110
- Catalog Number
- EIA-4110
- Company Name
- DRG International Inc
- Labeler DUNS
- 075150847
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-20
- Public Version
- 6
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 85b324fc-aa68-4ede-87ef-c6a55cc8a748
Device Description
The Quantitative Determination of Thyroglobulin (Tg) Autoantibodies in Human Serum or Plasma by a Microplate Enzyme Immunoassay, Colorimetric. Measurements of Tg autoantibodies may aid in the diagnosis of certain thyroid diseases such as Hashimoto’s and Grave’s as well as nontoxic goiter.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DDC | THYROGLOBULIN, ANTIGEN, ANTISERUM, CONTROL | Immunology | 866.5870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55209 | Multiple thyroid 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 the thyroid gland and/or specific products of thyroid gland metabolism in a clinical specimen, using an enzyme immunoassay (EIA) method. This test detects autoantibodies directed at antigens such as thyroid gland tissue, thyroglobulin, and thyroid peroxidase (TPO) [known as anti-microsomal antibody] to aid in the diagnosis of autoimmune thyroid diseases such as autoimmune thyroiditis (Hashimoto’s disease) and Graves’ disease. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840239041104 | GS1 |
Customer Contacts
- Phone
- +1(973)564-7555
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 20 | Milliliter | |
| Device Size Text, specify | Wash Solution | ||
| Device Size Text, specify | Calibrators | ||
| Total Volume | 13 | Milliliter | |
| Device Size Text, specify | Stop Solution | ||
| Total Volume | 1 | Milliliter | |
| Device Size Text, specify | Substrate B | ||
| Device Size Text, specify | Biotin Reagent | ||
| Device Size Text, specify | Substrate A | ||
| Total Volume | 7 | Milliliter | |
| Device Size Text, specify | Enzyme Reagent | ||
| Total Volume | 8 | Milliliter | |
| Device Size Text, specify | Serum Diluent |