Identity
- Trade Name
- PreChek FDA UDI
- Generic Name
- Buprenorphine IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 12 Multi Drug Test Round Cup (AMP1000•COC300•OXY100•THC50•PCP25•MDMA500•MOP300• BZO300• BAR300•MET1000• MTD300•BUP10) FDA UDI
- Model / Reference
- 21512050010308 FDA UDI
- Description
- 12 Multi Drug Test Round Cup (AMP1000•COC300•OXY100•THC50•PCP25•MDMA500•MOP300• BZO300• BAR300•MET1000• MTD300•BUP10) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857275007520 FDA UDI
- 510(k) Number
- K153050 FDA UDI
- FDA Product Code
- DJR FDA UDIDJC FDA UDIDIS FDA UDIJXM FDA UDIDNK FDA UDILCM FDA UDILDJ FDA UDIDJG FDA UDIDIO FDA UDIDKZ FDA UDI
- GMDN Term
- Buprenorphine IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3620 FDA UDI862.3610 FDA UDI862.3150 FDA UDI862.3170 FDA UDI862.3640 FDA UDI862.3870 FDA UDI862.3650 FDA UDI862.3250 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
Yes
FDA UDI
Over-the-Counter
Yes
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: 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
PreChek by Idun Solutions 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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- BluRapids™ — MERCEDES MEDICAL LLC · Class II
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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 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
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
- Idun Solutions Llc
Sources (1)
- FDA UDI 100fae57-ff25-4998-a322-1c5118aefcd8 34 fields · synced Jun 1, 2026