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KRONUS TSH RECEPTOR AUTOANTIBODY (TRAb) ELISA ASSAY KIT
FDA UDIClass II (US FDA UDI)
by Kronus, Inc.
Identity
- Trade Name
- KRONUS TSH RECEPTOR AUTOANTIBODY (TRAb) ELISA ASSAY KIT FDA UDI
- Generic Name
- Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- An enzyme linked immunosorbent assay for the semi-quantitative determination of antibodies to the thyroid stimulating hormone (TSH) receptor in human serum. FDA UDI
- Model / Reference
- KR7110 FDA UDI
- Description
- An enzyme linked immunosorbent assay for the semi-quantitative determination of antibodies to the thyroid stimulating hormone (TSH) receptor in human serum. FDA UDI
Identifiers
- Catalog Number
- KR7110 FDA UDI
- Primary DI / UDI-DI
- B126KR71100 FDA UDI
- FDA Product Code
- JZO FDA UDI
- GMDN Term
- Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA) 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: Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA)
KRONUS TSH RECEPTOR AUTOANTIBODY (TRAb) ELISA ASSAY KIT by Kronus, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA).
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- Zinc Transporter 8 Auto-Antibody (ZnT8) — 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 871bcf2e-3e3f-4b51-870e-5e0cc452b33c 35 fields · synced Jun 8, 2026