Identity
- Trade Name
- STEROID-SKREEN FDA UDI
- Generic Name
- 17-Hydroxycorticoid IVD, kit, spectrophotometry FDA UDI
- Device Name
- ETHANOL ANHYDROUS, 25mL FDA UDI
- Model / Reference
- 35064222 FDA UDI
- Description
- ETHANOL ANHYDROUS, 25mL FDA UDI
Identifiers
- Catalog Number
- 35064222 FDA UDI
- Primary DI / UDI-DI
- 00810042682108 FDA UDI
- FDA Product Code
- CDB FDA UDI
- GMDN Term
- 17-Hydroxycorticoid IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1385 FDA UDI
- Commercial Distribution
- Not 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
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
Steroid-Skreen by Biochemical Diagnostics Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biochemical Diagnostics Inc
Sources (1)
- FDA UDI 7f8c7763-8560-43ce-8a51-f240ad27f0ac 37 fields · synced Jun 1, 2026