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Dimension® EXL™ LOCI® Module Flex® reagent cartridge TNI
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Dimension® EXL™ LOCI® Module Flex® reagent cartridge TNI FDA UDI
- Generic Name
- Troponin I IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Cardiac Troponin I Flex® reagent cartridge, 144 tests FDA UDI
- Model / Reference
- 10464525 FDA UDI
- Description
- Cardiac Troponin I Flex® reagent cartridge, 144 tests FDA UDI
Identifiers
- Catalog Number
- RF621 FDA UDI
- Primary DI / UDI-DI
- 00842768022067 FDA UDI
- 510(k) Number
- K081643 FDA UDI
- FDA Product Code
- MMI FDA UDI
- GMDN Term
- Troponin I IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1215 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: Troponin I IVD, kit, chemiluminescent immunoassay
Dimension® EXL™ LOCI® Module Flex® reagent cartridge TNI by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Troponin I IVD, kit, chemiluminescent immunoassay.
- Access AccuTnI+3 — Beckman Coulter, Inc. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class I
- IMMULITE® 1000 Systems TPI Troponin I — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Access hsTnI Calibrators — Beckman Coulter, Inc. · Class II
- Alinity — ABBOTT IRELAND · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- PATHFAST hs-cTnI-II — PHC CORPORATION · Class II
- Elecsys Troponin I STAT Immunoassay — Roche Diagnostics Corp. · Class II
Cleared under the same submission
K081643 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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 259f26f4-5015-440b-822b-68d0246dd1d7 37 fields · synced May 31, 2026