Identity
- Trade Name
- FIRST SIGN® FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, control FDA UDI
- Device Name
- DOA 15 in 1 Test Controls Set, 1 Positive & 1 Negative Control (20mL each); First Sign for Hemosure FDA UDI
- Model / Reference
- D0115-TC02 FDA UDI
- Description
- DOA 15 in 1 Test Controls Set, 1 Positive & 1 Negative Control (20mL each); First Sign for Hemosure FDA UDI
Identifiers
- Catalog Number
- D0115-TC02 FDA UDI
- Primary DI / UDI-DI
- 00817763021698 FDA UDI
- FDA Product Code
- DIF FDA UDI
- GMDN Term
- Multiple drugs of abuse 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple drugs of abuse IVD, control
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Hemosure Inc.
Sources (1)
- FDA UDI 58e94f21-240e-4a6b-89cb-a9fbe6574703 34 fields · synced Jul 24, 2026