Identity
- Trade Name
- Dimension® Flex® reagent cartridge URCA FDA UDI
- Generic Name
- Uric acid IVD, kit, spectrophotometry FDA UDI
- Device Name
- Uric Acid Flex® reagent cartridge, 480 tests FDA UDI
- Model / Reference
- 10444967 FDA UDI
- Description
- Uric Acid Flex® reagent cartridge, 480 tests FDA UDI
Identifiers
- Catalog Number
- DF77 FDA UDI
- Primary DI / UDI-DI
- 00842768014192 FDA UDI
- 510(k) Number
- K862359 FDA UDI
- FDA Product Code
- KNK FDA UDICIG FDA UDI
- GMDN Term
- Uric acid IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1775 FDA UDI862.1110 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: Uric acid IVD, kit, spectrophotometry
Dimension® Flex® reagent cartridge URCA by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uric acid IVD, kit, spectrophotometry.
- Uric Acid ver.2 — Roche Diagnostics Corp. · Class I
- CAROLINA LIQUID CHEMISTRIES CORP.® URIC ACID REAGENT KIT DT212 — Carolina Liquid Chemistries Corp. · Class I
- URIC ACID MONO SL — VITALSCIENTIFIC
- Alinity — ABBOTT IRELAND · Class I
- Alinity — ABBOTT IRELAND · Class I
- Uric Acid LiquiColor® — STANBIO LABORATORY, L.P. · Class I
- ARCHITECT — ABBOTT IRELAND · Class I
- ARCHITECT — Abbott · Class I
Cleared under the same submission
K862359 also covers:
- Dimension® Flex® reagent cartridge CHK — Siemens Healthcare Diagnostics
- Dimension® Flex® reagent cartridge T4 — Siemens Healthcare Diagnostics
- Dimension® Flex® reagent cartridge TU — Siemens Healthcare Diagnostics
- Dimension® T4 Calibrator — Siemens Healthcare Diagnostics
- Dimension® TU Calibrator — Siemens Healthcare Diagnostics
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 4f0eac11-49c2-488d-a72a-96c12b78a1ad 37 fields · synced May 30, 2026