Identity
- Trade Name
- STEROID-SKREEN FDA UDI
- Generic Name
- 17-Hydroxycorticoid IVD, reagent FDA UDI
- Device Name
- ELUTION SOLVENT, 80% Ethanol, 4L FDA UDI
- Model / Reference
- 35066422 FDA UDI
- Description
- ELUTION SOLVENT, 80% Ethanol, 4L FDA UDI
Identifiers
- Catalog Number
- 35066422 FDA UDI
- Primary DI / UDI-DI
- 00810042682177 FDA UDI
- FDA Product Code
- CDB FDA UDI
- GMDN Term
- 17-Hydroxycorticoid IVD, reagent 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 |
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Manufacturer
- Manufacturer
- Biochemical Diagnostics Inc
Sources (1)
- FDA UDI bd1614d3-780f-4671-b8b2-9fac6bd8ed39 37 fields · synced Jun 6, 2026