Identity
- Trade Name
- Dimension Vista® Flex® reagent cartridge CHOL FDA UDI
- Generic Name
- Total cholesterol lipid IVD, kit, spectrophotometry FDA UDI
- Device Name
- Cholesterol Flex® reagent cartridge, 600 tests FDA UDI
- Model / Reference
- 10445143 FDA UDI
- Description
- Cholesterol Flex® reagent cartridge, 600 tests FDA UDI
Identifiers
- Catalog Number
- K1027 FDA UDI
- Primary DI / UDI-DI
- 00842768015090 FDA UDI
- 510(k) Number
- K061655 FDA UDI
- FDA Product Code
- CHH FDA UDI
- GMDN Term
- Total cholesterol lipid IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1175 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: Total cholesterol lipid IVD, kit, spectrophotometry
Dimension Vista® Flex® reagent cartridge CHOL by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total cholesterol lipid IVD, kit, spectrophotometry.
- Pointe Cholesterol Reagent — POINTE SCIENTIFIC, INC. · Class I
- STANDARD™ LipidoCare Analyzer — Sd Biosensor · Class I
- STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile — Sd Biosensor · Class I
- Cholesterol Gen.2 — Roche Diagnostics Corp. · Class I
- Cholesterol LiquiColor® — STANBIO LABORATORY, L.P. · Class I
- Cholesterol LiquiColor® — STANBIO LABORATORY, L.P. · Class I
- POINTE SCIENTIFIC Cholesterol (Liquid) — POINTE SCIENTIFIC, INC. · Class I
- CHOLESTEROL (CHOL) — Randox Laboratories, Ltd. · Class I
Cleared under the same submission
K061655 also covers:
- Dimension Vista® Flex® reagent cartridge ACTM — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge AMY — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge GGT — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge GLU — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge LDLC — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge LIDO — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge PCHE — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge PHOS — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge SAL — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge T4 — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge TOBR — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge TRIG — 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 59093a37-fe12-490f-9606-436f5cd6eb60 37 fields · synced May 30, 2026