← Back to catalogue
T3, T4, TSH Thyroid Panel AccuLite VAST AccuLite CLIA Test System - 480 Wells
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- T3, T4, TSH Thyroid Panel AccuLite VAST AccuLite CLIA Test System - 480 Wells FDA UDI
- Generic Name
- Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 8075-300 FDA UDI
Identifiers
- Catalog Number
- 8075-300D FDA UDI
- Primary DI / UDI-DI
- 00816870023335 FDA UDI
- FDA Product Code
- JLW FDA UDI
- GMDN Term
- Total triiodothyronine (TT3) 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
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
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: Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay
T3, T4, TSH Thyroid Panel AccuLite VAST AccuLite CLIA Test System - 480 Wells by Monobind, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay.
- VITROS — Ortho-Clinical Diagnostics · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- ARCHITECT — ABBOTT IRELAND · Class II
- ARCHITECT — ABBOTT IRELAND · Class I
- ARCHITECT — ABBOTT IRELAND · Class II
- IMMULITE®/IMMULITE® 1000 Systems T3 Total T3 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Elecsys T3 — Roche Diagnostics Corp. · Class II
- ADVIA Centaur® T3 — Siemens Healthcare Diagnostics · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Monobind, Inc.
Sources (1)
- FDA UDI d1d756bf-49f7-4164-b2a9-f10649bbb7ce 36 fields · synced May 30, 2026