Identity
- Trade Name
- Alinity FDA UDI
- Generic Name
- Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Alinity c Amphetamine/Methamphetamine Reagent Kit 400 Tests FDA UDI
- Model / Reference
- 09P4520 FDA UDI
- Description
- Alinity c Amphetamine/Methamphetamine Reagent Kit 400 Tests FDA UDI
Identifiers
- Catalog Number
- 09P4520 FDA UDI
- Primary DI / UDI-DI
- 00380740172329 FDA UDI
- 510(k) Number
- K093114 FDA UDI
- FDA Product Code
- LAF FDA UDIDKZ FDA UDI
- GMDN Term
- Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3610 FDA UDI862.3100 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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)
Alinity by Abbott Laboratories, Inc. — 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).
- Dimension Vista® Flex® reagent cartridge EXTC — Siemens Healthcare Diagnostics · 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
- Ecstasy Enzyme Immunoassay — Lin-Zhi International, Inc. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® XTSY RGT. KIT AU-423 — Carolina Liquid Chemistries Corp. · Class II
- Amphetamines Enzyme Immunoassay — Lin-Zhi International, Inc. · Class II
Cleared under the same submission
K093114 also covers:
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
- Abbott Laboratories, Inc.
Sources (1)
- FDA UDI b3808411-af1f-4bd6-8fe0-f7a1eb3d0c11 37 fields · synced May 30, 2026