Identity
- Trade Name
- FIRST SIGN® FDA UDI
- Generic Name
- Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- DOA Single Test Dip card, 25Pcs/Box; First Sign for Hemosure COC FDA UDI
- Model / Reference
- FSCWCO-25 FDA UDI
- Description
- DOA Single Test Dip card, 25Pcs/Box; First Sign for Hemosure COC FDA UDI
Identifiers
- Catalog Number
- FSCWCO-25 FDA UDI
- Primary DI / UDI-DI
- 00857338006545 FDA UDI
- FDA Product Code
- DIO FDA UDI
- GMDN Term
- Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical 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
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: Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
First Sign® by Hemosure Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Hemosure Inc.
Sources (1)
- FDA UDI 188be058-bed6-48e0-95cf-1a7f9d18959b 34 fields · synced Jun 8, 2026