FDA UDI
In Commercial Distribution
🇺🇸 United States
Thyroid Stimulating Hormone (TSH) ELISA
DI: 00840239017826
·
Model: EIA-1782
·
DRG International Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Thyroid Stimulating Hormone (TSH) ELISA
- Primary DI
- 00840239017826
- Version / Model
- EIA-1782
- Catalog Number
- EIA-1782
- 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
- 4
- Public Version Date
- 2023-08-16
- Public Version Status
- Update
- Public Device Record Key
- f4c9d754-18c2-460c-81a0-5eefe49dfcb0
Device Description
For the quantitative determination of thyroid stimulating hormone (TSH) concentration in human serum. The assay is useful in the diagnosis of thyroid or pituitary disorders.
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 |
|---|---|---|---|---|
| JLW | RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE | Clinical Chemistry | 862.1690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61252 | Multiple thyroid marker 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 multiple thyroid markers associated with thyroid disease in a clinical specimen using an enzyme immunoassay (EIA) method. Analytes detected may include, but are not limited to, free triiodothyronine (FT3), free thyroxine (FT4), thyroid stimulating hormone (TSH) and/or thyroid peroxidase (TPO). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840239017826 | GS1 |
Customer Contacts
- Phone
- +1(973)564-7555
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 13 | Milliliter | |
| Device Size Text, specify | Conjugate Reagent | ||
| Device Size Text, specify | Stop Solution | ||
| Device Size Text, specify | Standards | ||
| Total Volume | 1 | Milliliter | |
| Device Size Text, specify | TMB Reagent | ||
| Total Volume | 11 | Milliliter |