Identity
- Trade Name
- Dimension Vista® Flex® reagent cartridge THC FDA UDI
- Generic Name
- Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Urine Cannabinoids Screen Flex® reagent cartridge, 120 tests FDA UDI
- Model / Reference
- 10445116 FDA UDI
- Description
- Urine Cannabinoids Screen Flex® reagent cartridge, 120 tests FDA UDI
Identifiers
- Catalog Number
- K5095 FDA UDI
- Primary DI / UDI-DI
- 00842768015441 FDA UDI
- 510(k) Number
- K062128 FDA UDI
- FDA Product Code
- LDJ FDA UDI
- GMDN Term
- Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3870 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: Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Dimension Vista® Flex® reagent cartridge THC by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA).
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- Pointe Cannabinoid (THC) Reagent Set — POINTE SCIENTIFIC, INC. · Class II
- Immunalysis — Immunalysis Corporation · Class II
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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 COC — 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
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 8526b915-5df0-4c69-9cb1-51c9d7b60b39 37 fields · synced Jun 8, 2026