Identity
- Trade Name
- AIMSTEP THYROID SCREEN FDA UDI
- Generic Name
- Thyroid stimulating hormone (TSH) IVD, reagent FDA UDI
- Device Name
- Cassette test for TSH in fingerstick whole blood FDA UDI
- Model / Reference
- 76220 FDA UDI
- Description
- Cassette test for TSH in fingerstick whole blood FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00695684762209 FDA UDI
- FDA Product Code
- JLW FDA UDI
- GMDN Term
- Thyroid stimulating hormone (TSH) IVD, reagent 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
No
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, reagent
Aimstep Thyroid Screen by Germaine Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thyroid stimulating hormone (TSH) IVD, reagent.
- Boditech TSH Calibrator — Boditech Med, Inc. · Class I
- Boditech TSH Control — Boditech Med, Inc. · Class II
- AFIAS TSH-SP — Boditech Med, Inc. · Class I
- AFIAS-6/VB Analyzer — Boditech Med, Inc. · Class II
- AFIAS-6/SP Analyzer — Boditech Med, Inc. · Class I
- AFIAS TSH-VB — Boditech Med, 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
- Germaine Laboratories, Inc.
Sources (1)
- FDA UDI c2b7d668-5a82-41e7-8578-7d93e1fb732d 33 fields · synced May 31, 2026