← Back to catalogue
Dimension Cardiac Troponin-I Flex reagent cartridge
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Dimension Cardiac Troponin-I Flex reagent cartridge FDA UDI
- Generic Name
- Troponin I IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Cardiac Troponin-I Flex® reagent cartridge, 120 tests FDA UDI
- Model / Reference
- 10444905 FDA UDI
- Description
- Cardiac Troponin-I Flex® reagent cartridge, 120 tests FDA UDI
Identifiers
- Catalog Number
- RF421C FDA UDI
- Primary DI / UDI-DI
- 00842768013836 FDA UDI
- 510(k) Number
- K010313 FDA UDI
- FDA Product Code
- MMI FDA UDI
- GMDN Term
- Troponin I IVD, kit, enzyme immunoassay (EIA) 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, enzyme immunoassay (EIA)
Dimension Cardiac Troponin-I Flex reagent cartridge by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Troponin I IVD, kit, enzyme immunoassay (EIA).
- cTnI AccuBind ELISA Test System - 96 Wells — MONOBIND, INC. · Class II
- ST AIA-PACK cTnI 2 — Tosoh Corp. · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- cTnI AccuBind ELISA Test System - 192 Wells — MONOBIND, INC. · Class II
- i-STAT hs-TnI cartridge — Abbott Point of Care Inc. · Class II
- Dimension Cardiac Troponin-I Flex reagent cartridge — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K010313 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 2292292c-3945-46db-9e7f-2de00c82abc8 37 fields · synced Jun 1, 2026