Identity
- Trade Name
- Dimension Vista® Flex® reagent cartridge COC FDA UDI
- Generic Name
- Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA), FDA UDI
- Device Name
- Urine Cocaine Flex® reagent cartridge, 120 tests FDA UDI
- Model / Reference
- 10445113 FDA UDI
- Description
- Urine Cocaine Flex® reagent cartridge, 120 tests FDA UDI
Identifiers
- Catalog Number
- K5092 FDA UDI
- Primary DI / UDI-DI
- 00842768015120 FDA UDI
- 510(k) Number
- K062128 FDA UDI
- FDA Product Code
- DIO FDA UDI
- GMDN Term
- Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA), FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3250 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: Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),
Dimension Vista® Flex® reagent cartridge COC by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),.
- CEDIA Cocaine Assay — Microgenics Corporation · Class II
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- Pointe Cocaine Metabolite 150 Reagent Set — POINTE SCIENTIFIC, INC. · Class II
- Cocaine Metabolite Enzyme Immunoassay — Lin-Zhi International, Inc. · Class II
- Pointe Cocaine Metabolite 150 Reagent Set — POINTE SCIENTIFIC, INC. · Class II
- Cocaine Metabolite 150 Enzyme Immunoassay — Lin-Zhi International, Inc. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® COCM RGT. KIT ST413 — Carolina Liquid Chemistries Corp. · Class II
Cleared under the same submission
K062128 also covers:
- Dimension Vista® Flex® reagent cartridge AMPH — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge BARB — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge BENZ — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge EXTC — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge METH — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge OPI — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge PCP — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge THC — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 8219d035-6cb6-471b-b9a1-76503cd8c291 37 fields · synced May 30, 2026