Identity
- Trade Name
- Rapid Response FDA UDI
- Generic Name
- Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Rapid Response Thyroid Stimulating Hormone Test Cassettes - 20 tests/ kit are for the qualitative detection of TSH in serum, plasma or whole blood. FDA UDI
- Model / Reference
- TSH-13C20 FDA UDI
- Description
- Rapid Response Thyroid Stimulating Hormone Test Cassettes - 20 tests/ kit are for the qualitative detection of TSH in serum, plasma or whole blood. FDA UDI
Identifiers
- Catalog Number
- TSH-13C20 FDA UDI
- Primary DI / UDI-DI
- 00722066001646 FDA UDI
- 510(k) Number
- K030912 FDA UDI
- FDA Product Code
- JLW FDA UDI
- GMDN Term
- Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1690 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
Yes
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 (TSH) IVD, kit, enzyme immunoassay (EIA)
Rapid Response by BTNX Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA).
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- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- Thyrotropin (TSH) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- Monobind AccuBind TSH Rapid ELISA Kit - 96 Wells — MONOBIND, INC. · Class II
- AIA-PACK TSH 3rd-Gen — Tosoh Corp. · Class II
- Thyrotropin (TSH) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
Cleared under the same submission
K030912 also covers:
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
- BTNX Inc
Sources (1)
- FDA UDI 7faf1112-0890-4223-83a2-ed47af810ea2 35 fields · synced May 30, 2026