FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Total Triiodothyronine T3 ELISA (Total T3 ELISA)
DI: B24225TRIHUE010
·
Model: 25-TRIHU-E01
·
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Total Triiodothyronine T3 ELISA (Total T3 ELISA)
- Primary DI
- B24225TRIHUE010
- Version / Model
- 25-TRIHU-E01
- Catalog Number
- 25-TRIHU-E01
- Company Name
- AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
- Labeler DUNS
- 784143778
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-03
- Public Version
- 4
- Public Version Date
- 2022-09-20
- Public Version Status
- Update
- Public Device Record Key
- 13eddf2b-931d-4d44-9853-2cdd1da01995
- Distribution End Date
- 2019-02-19
Device Description
The Total Triiodothyronine T3 ELISA (Total T3 ELISA) is intended for use in the quantitative determination of triiodothyronine (T3) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.
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
- 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 |
|---|---|---|---|---|
| CDP | Radioimmunoassay, Total Triiodothyronine | Clinical Chemistry | 862.1710 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58332 | Total triiodothyronine (TT3) IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the quantitative measurement of total triiodothyronine (TT3) 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 | B24225TRIHUE010 | HIBCC |
Customer Contacts
- Phone
- 800.592.5726
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius