Identity
- Trade Name
- Dimension® Flex® reagent cartridge EXTC FDA UDI
- Generic Name
- Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Urine Ecstasy Screen Flex® reagent cartridge, 80 tests FDA UDI
- Model / Reference
- 10444921 FDA UDI
- Description
- Urine Ecstasy Screen Flex® reagent cartridge, 80 tests FDA UDI
Identifiers
- Catalog Number
- DF109 FDA UDI
- Primary DI / UDI-DI
- 00842768014710 FDA UDI
- 510(k) Number
- K053337 FDA UDI
- FDA Product Code
- DKZ FDA UDI
- GMDN Term
- Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3100 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: Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
Dimension® Flex® reagent cartridge EXTC by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA).
- Alinity — Abbott Laboratories, Inc. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® XTSY RGT KIT Product No. DT423 — Carolina Liquid Chemistries Corp. · Class II
- Amphetamines 500 Enzyme Immunoassay — Lin-Zhi International, Inc. · Class II
- Amphetamines 500 Enzyme Immunoassay — Lin-Zhi International, Inc. · Class II
- Immunalysis — Immunalysis Corporation · Class II
- Alinity — Abbott Laboratories, Inc. · Class II
- Ecstasy Enzyme Immunoassay — Lin-Zhi International, Inc. · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
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 a6e89533-10a9-4999-b763-6df39473be8e 37 fields · synced May 30, 2026