Identity
- Trade Name
- Cocaine OraSure 100 Plate Kit FDA UDI
- Generic Name
- Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA), FDA UDI
- Model / Reference
- 1122SC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00608337000429 FDA UDI
- 510(k) Number
- K982061 FDA UDI
- FDA Product Code
- DIO 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 UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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: Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),
Cocaine OraSure 100 Plate Kit by OraSure Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K982061 also covers:
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
- OraSure Technologies, Inc.
Sources (1)
- FDA UDI 400ab4e5-807b-49dd-ba0b-5d810758f346 34 fields · synced Jun 9, 2026