Identity
- Trade Name
- CLIAwaived FDA UDI
- Generic Name
- Benzodiazepine group IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Single Drug Dipstick Test for BZO300 FDA UDI
- Model / Reference
- CLIA-SDDT-18 FDA UDI
- Description
- Single Drug Dipstick Test for BZO300 FDA UDI
Identifiers
- Catalog Number
- CLIA-SDDT-18 FDA UDI
- Primary DI / UDI-DI
- 00816610020204 FDA UDI
- 510(k) Number
- K022355 FDA UDI
- FDA Product Code
- JXM FDA UDI
- GMDN Term
- Benzodiazepine group IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3170 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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: Benzodiazepine group IVD, kit, rapid ICT, clinical
CLIAwaived by Cliawaived, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Benzodiazepine group IVD, kit, rapid ICT, clinical.
- u-Card — UCP BIOSCIENCES, INC. · Class II
- BluRapids™ — MERCEDES MEDICAL LLC · Class II
- DrugCheck — Express Diagnostic Int'l, Inc. · Class II
- Status DS™ 9 card — PRINCETON BIOMEDITECH CORP. · Class II
- N/M — IDUN SOLUTIONS LLC · Class II
- UScreen — Guangzhou Decheng Biotechnology Co., LTD · Class II
- Amazewell — Guangzhou Decheng Biotechnology Co., LTD · Class II
- UScreen Oral — Guangzhou Decheng Biotechnology Co., LTD · Class II
Cleared under the same submission
K022355 also covers:
- CLIAwaived — CLIAWAIVED,INC.
- CLIAwaived — CLIAWAIVED,INC.
- CLIAwaived — CLIAWAIVED,INC.
- CLIAwaived — CLIAWAIVED,INC.
- CLIAwaived — CLIAWAIVED,INC.
- CLIAwaived — CLIAWAIVED,INC.
- Alere iScreen Dx — Instant Technologies, Inc.
- Alere iScreen Dx — Instant Technologies, Inc.
- Alere iScreen Dx — Instant Technologies, Inc.
- Alere iScreen Dx — Instant Technologies, Inc.
- Alere iScreen Dx — Instant Technologies, Inc.
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
- Cliawaived, Inc.
Sources (1)
- FDA UDI 4e0a770b-8243-4d3f-8bdb-a8a9c28d17f6 37 fields · synced May 30, 2026