Identity
- Trade Name
- STEROID-SKREEN FDA UDI
- Generic Name
- 17-Ketogenic steroid (17KGS) IVD, reagent FDA UDI
- Device Name
- SODIUM METAPERIODATE, 7g FDA UDI
- Model / Reference
- 35061401 FDA UDI
- Description
- SODIUM METAPERIODATE, 7g FDA UDI
Identifiers
- Catalog Number
- 35061401 FDA UDI
- Primary DI / UDI-DI
- 00810042681859 FDA UDI
- FDA Product Code
- CCZ FDA UDI
- GMDN Term
- 17-Ketogenic steroid (17KGS) 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 5ca3ba11-3b13-4066-b0f0-5686772f2f39 37 fields · synced May 30, 2026