← Back to catalogue
Dimension® EXL™ LOCI® Module Flex® reagent cartridge TSHL
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Dimension® EXL™ LOCI® Module Flex® reagent cartridge TSHL FDA UDI
- Generic Name
- Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- LOCI Thyroid Stimulating Hormone Flex® reagent cartridge, 200 tests FDA UDI
- Model / Reference
- 10464524 FDA UDI
- Description
- LOCI Thyroid Stimulating Hormone Flex® reagent cartridge, 200 tests FDA UDI
Identifiers
- Catalog Number
- RF612 FDA UDI
- Primary DI / UDI-DI
- 00842768022081 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
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, chemiluminescent immunoassay
Dimension® EXL™ LOCI® Module Flex® reagent cartridge TSHL by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay.
- TSH AccuLite CLIA Test System - 960 Wells — MONOBIND, INC. · Class II
- Monobind AccuLite T3, T4, TSH CLIA Kit - 192 Wells — MONOBIND, INC. · Class II
- IMMULITE® 2000 Systems TSH Third Generation TSH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Monobind AccuLite fT3, Ft4, TSH CLIA Kit - 480 Wells — MONOBIND, INC. · 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
- TSH AccuLite CLIA Test System - 96 Wells — MONOBIND, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI f1022547-b097-43fe-b3f2-cb9925e05b61 36 fields · synced Jun 8, 2026