Identity
- Trade Name
- BluRapids FDA UDI
- Generic Name
- Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- BluRapids Concise CLIA Waived Drug Cup; 12-Panel; AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/OPI300/OXY/PCP/THC FDA UDI
- Model / Reference
- TNR CDOA6125M FDA UDI
- Description
- BluRapids Concise CLIA Waived Drug Cup; 12-Panel; AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/OPI300/OXY/PCP/THC FDA UDI
Identifiers
- Catalog Number
- TNR CDOA6125M FDA UDI
- Primary DI / UDI-DI
- 00850011007280 FDA UDI
- 510(k) Number
- K133968 FDA UDI
- FDA Product Code
- LDJ FDA UDILCM FDA UDIDJR FDA UDIDNK FDA UDIDJC FDA UDIDIO FDA UDIJXM FDA UDIDJG FDA UDIDIS 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 UDI862.3620 FDA UDI862.3640 FDA UDI862.3610 FDA UDI862.3250 FDA UDI862.3170 FDA UDI862.3650 FDA UDI862.3150 FDA UDI862.3100 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
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
Yes
FDA UDI
Category: Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinicalCocaine/cocaine metabolite IVD, kit, rapid ICT, clinicalAmphetamine-specific IVD, kit, rapid ICT, clinicalBarbiturate IVD, kit, rapid ICT, clinical
BluRapids by Mercedes Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Buprenorphine IVD, kit, enzyme immunoassay (EIA).
- 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
- CIBIO Test — Co-Innovation Biotech Co., Ltd · Class II
- Immunalysis — Immunalysis Corporation · Class II
- Pointe Buprenorphine Reagent Set — POINTE SCIENTIFIC, INC. · Class II
- Pointe Buprenorphine Reagent Set — POINTE SCIENTIFIC, INC. · Class II
Cleared under the same submission
K133968 also covers:
- CLIAwaived — CLIAWAIVED,INC.
- Areta Multi-Drug Test Cup (10 tests kit) — EASY HEALTHCARE CORPORATION
- Areta Multi-Drug Test Cup (25 tests kit) — EASY HEALTHCARE CORPORATION
- Areta Multi-Drug Test Cup (50 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home COC Single Drug Screen Test (25 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home Multi-Drug Screen Test (10 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home Multi-Drug Screen Test (10 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home Multi-Drug Screen Test (10 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home Multi-Drug Screen Test (2 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home Multi-Drug Screen Test (25 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home Multi-Drug Screen Test (5 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home Multi-Drug Test Cup (25 tests kit) — EASY HEALTHCARE CORPORATION
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
- Mercedes Medical Llc
Sources (1)
- FDA UDI 7072e8ca-cfcb-45d6-a552-c694785036fb 37 fields · synced May 31, 2026