Identity
- Trade Name
- BluRapids™ FDA UDI
- Generic Name
- Tricyclic antidepressant IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- BluRapids CLIA Waived Drug Cup; 12 Panel BluRapids AMP/BAR/BUP/BZO/COC/MET/MDMA/OPI-300/MTD/OXY/PCP/TCA FDA UDI
- Model / Reference
- TNR MMC12MOP FDA UDI
- Description
- BluRapids CLIA Waived Drug Cup; 12 Panel BluRapids AMP/BAR/BUP/BZO/COC/MET/MDMA/OPI-300/MTD/OXY/PCP/TCA FDA UDI
Identifiers
- Catalog Number
- TNR MMC12MOP FDA UDI
- Primary DI / UDI-DI
- 00850011007099 FDA UDI
- 510(k) Number
- K153050 FDA UDI
- FDA Product Code
- LFG FDA UDILCM FDA UDIDJR FDA UDIDNK FDA UDIDJC FDA UDIDIO FDA UDIJXM FDA UDIDJG FDA UDIDIS FDA UDIDKZ FDA UDI
- GMDN Term
- Tricyclic antidepressant IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3910 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
No
FDA UDI
Category: Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinicalBarbiturate IVD, kit, rapid ICT, clinicalAmphetamine-specific IVD, kit, rapid ICT, clinicalMethamphetamine-specific IVD, kit, rapid ICT, clinical
BluRapids™ by Mercedes Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Buprenorphine IVD, kit, enzyme immunoassay (EIA).
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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
- 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
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 |
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Manufacturer
- Manufacturer
- Mercedes Medical Llc
Sources (1)
- FDA UDI 51221d49-68b3-4358-b35b-0a242b5ebf9f 37 fields · synced Jun 6, 2026