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125I TSH Receptor Antibody Kit (TRAb PEG) (No Calibrators)
FDA UDIClass II (US FDA UDI)
by Kronus, Inc.
Identity
- Trade Name
- 125I TSH Receptor Antibody Kit (TRAb PEG) (No Calibrators) FDA UDI
- Generic Name
- Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, radioimmunoassay FDA UDI
- Device Name
- A radioimmunoassay for the qualitative determination of antibodies to the thyroid stimulating hormone (TSH) receptor in human serum. FDA UDI
- Model / Reference
- KR6160 FDA UDI
- Description
- A radioimmunoassay for the qualitative determination of antibodies to the thyroid stimulating hormone (TSH) receptor in human serum. FDA UDI
Identifiers
- Catalog Number
- KR6160 FDA UDI
- Primary DI / UDI-DI
- B126KR61600 FDA UDI
- FDA Product Code
- JZO FDA UDI
- GMDN Term
- Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, radioimmunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5870 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, radioimmunoassay
125I TSH Receptor Antibody Kit (TRAb PEG) (No Calibrators) by Kronus, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, radioimmunoassay.
- Accutest TSH Test — JANT PHARMACAL CORP. · Class II
- 125I TSH Receptor Antibody Kit (TRAb PEG) (No Calibrators) — KRONUS, INC. · Class II
- TSH RECEPTOR ANTIBODY (TRAb) COATED TUBE (CT) ASSAY KIT — KRONUS, INC. · Class II
- TSH RECEPTOR ANTIBODY (TRAb) COATED TUBE (CT) ASSAY KIT — KRONUS, INC. · Class II
- 125I TSH Receptor Antibody Kit (TRAb PEG) (With Calibrators) — KRONUS, INC. · Class II
- 125I TSH Receptor Antibody Kit (TRAb PEG) (With Calibrators) — KRONUS, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Kronus, Inc.
Sources (1)
- FDA UDI 90755f27-7472-450a-a188-bc7753e2813a 35 fields · synced May 31, 2026