Identity
- Trade Name
- co-innovation FDA UDI
- Generic Name
- Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- 7P Rapid Multi-Drug Test Cup FDA UDI
- Model / Reference
- DOA7PC FDA UDI
- Description
- 7P Rapid Multi-Drug Test Cup FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970429840706 FDA UDI
- 510(k) Number
- K153050 FDA UDI
- FDA Product Code
- LDJ FDA UDIDNK FDA UDIDJC FDA UDIDIO FDA UDIDJG FDA UDIJXM FDA UDIDKZ FDA UDI
- GMDN Term
- Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3870 FDA UDI862.3640 FDA UDI862.3610 FDA UDI862.3250 FDA UDI862.3650 FDA UDI862.3170 FDA UDI862.3100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinicalCocaine/cocaine metabolite IVD, kit, rapid ICT, clinicalAmphetamine-specific IVD, kit, rapid ICT, clinicalMethamphetamine-specific IVD, kit, rapid ICT, clinical
co-innovation by Co-Innovation Biotech Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Buprenorphine IVD, kit, enzyme immunoassay (EIA).
- BluRapids™ — MERCEDES MEDICAL LLC · Class II
- Immunalysis — Immunalysis Corporation · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® BUP REAGENT KIT Product No. DT424 — Carolina Liquid Chemistries Corp. · Class II
- Buprenorphine Enzyme Immunoassay — Lin-Zhi International, Inc. · Class II
- PreChek Multi-Drug Test Square Cup — IDUN SOLUTIONS LLC · Class II
- Tanner Scientific® — MERCEDES MEDICAL LLC · Class II
- BluRapids™ — MERCEDES MEDICAL LLC · Class II
- Immunalysis — Immunalysis Corporation · Class II
Cleared under the same submission
K153050 also covers:
- CIBIO Test — Co-Innovation Biotech Co., Ltd
- CIBIO Test — Co-Innovation Biotech Co., Ltd
- Co-innovation — Co-Innovation Biotech Co., Ltd
- co-innovation — Co-Innovation Biotech Co., Ltd
- co-innovation — Co-Innovation Biotech Co., Ltd
- PreChek — IDUN SOLUTIONS LLC
- PreChek — IDUN SOLUTIONS LLC
- PreChek Multi-Drug Test Square Cup — IDUN SOLUTIONS LLC
- PreKnow — IDUN SOLUTIONS LLC
- PreKnow — IDUN SOLUTIONS LLC
- PreKnow — IDUN SOLUTIONS LLC
- PreKnow — IDUN SOLUTIONS LLC
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Co-Innovation Biotech Co., Ltd
Sources (1)
- FDA UDI e07f438f-844b-439d-ba0d-f21f643df3e9 34 fields · synced Jun 1, 2026