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Monobind AccuLite fT3, Ft4, TSH CLIA Kit - 480 Wells
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Monobind AccuLite fT3, Ft4, TSH CLIA Kit - 480 Wells FDA UDI
- Generic Name
- Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 7075-300 FDA UDI
Identifiers
- Catalog Number
- 7075-300D FDA UDI
- Primary DI / UDI-DI
- 00816870023304 FDA UDI
- FDA Product Code
- JLW FDA UDI
- GMDN Term
- Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 7.75 Inch FDA UDI
Category: Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
Monobind AccuLite fT3, Ft4, TSH CLIA Kit - 480 Wells by Monobind, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay.
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- IMMULITE® 2000 Systems TSH Third Generation TSH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- ADVIA Centaur® TSH — Siemens Healthcare Diagnostics · Class II
- Alinity — ABBOTT IRELAND · Class II
- Alinity — ABBOTT IRELAND · Class II
- IMMULITE®/IMMULITE® 1000 Systems RTH Rapid TSH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · 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
- Monobind, Inc.
Sources (1)
- FDA UDI 24c6822b-db35-4e18-9b74-ed4c80c6d55d 36 fields · synced Jun 1, 2026