Identity
- Trade Name
- ACCU NEWS Multi-Drug Screen Test FDA UDI
- Generic Name
- Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA), FDA UDI
- Device Name
- 5 pcs/box FDA UDI
- Model / Reference
- Multi-panel FDA UDI
- Description
- 5 pcs/box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850042559024 FDA UDI
- 510(k) Number
- K152590 FDA UDI
- FDA Product Code
- DIO FDA UDIDJC FDA UDIDJG FDA UDIDKZ FDA UDILDJ FDA UDI
- GMDN Term
- Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA), FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3250 FDA UDI862.3610 FDA UDI862.3650 FDA UDI862.3100 FDA UDI862.3870 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
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
Yes
Category: Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA)Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA)
ACCU NEWS Multi-Drug Screen Test by Coretests, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Coretests, Inc.
Sources (1)
- FDA UDI 7717c84a-f288-4094-8167-9c3efec58ad7 34 fields · synced May 30, 2026