Identity
- Trade Name
- COCAINE PLUS 800 NG/ML FDA UDI
- Generic Name
- Cocaine/cocaine metabolite IVD, control FDA UDI
- Device Name
- COCAINE PLUS 800 NG/ML FDA UDI
- Model / Reference
- COC+ 800 U FDA UDI
- Description
- COCAINE PLUS 800 NG/ML FDA UDI
Identifiers
- Catalog Number
- COC+ 800 U FDA UDI
- Primary DI / UDI-DI
- B800COC800U0 FDA UDI
- FDA Product Code
- LAS FDA UDI
- GMDN Term
- Cocaine/cocaine metabolite IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3280 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 5 Milliliter FDA UDI
Category: Cocaine/cocaine metabolite IVD, control
Cocaine Plus 800 Ng/Ml by Utak Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cocaine/cocaine metabolite IVD, control.
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- Pointe Cocaine Metabolite 150 Level 1 Control (BE 112.5 ng/mL) — POINTE SCIENTIFIC, INC. · Class I
- Cocaine Metabolite 150 DAU Control, Level 1 Control — Lin-Zhi International, Inc. · Class I
- Pointe Cocaine Level 1 Control (BE 225 ng/mL) — POINTE SCIENTIFIC, INC. · Class I
- Cocaine Metabolite DAU Control, Level 1 Control — Lin-Zhi International, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Utak Laboratories, Inc.
Sources (1)
- FDA UDI c5b0d0c7-7b47-41c7-a540-5b7d0f6ec186 37 fields · synced Jun 8, 2026