Identity
- Trade Name
- Androstenedione ELISA FDA UDI
- Generic Name
- Androstenedione IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Androstenedione ELISA is for the direct quantitative determination of androstenedione in human serum by an enzyme immunoassay. For In Vitro Diagnostic Use. FDA UDI
- Model / Reference
- 11-ANRHU-E01 FDA UDI
- Description
- The Androstenedione ELISA is for the direct quantitative determination of androstenedione in human serum by an enzyme immunoassay. For In Vitro Diagnostic Use. FDA UDI
Identifiers
- Catalog Number
- 11-ANRHU-E01 FDA UDI
- Primary DI / UDI-DI
- B24211ANRHUE010 FDA UDI
- FDA Product Code
- CIZ FDA UDI
- GMDN Term
- Androstenedione IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1075 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: Androstenedione IVD, kit, enzyme immunoassay (EIA)
Androstenedione ELISA by American Laboratory Products Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Androstenedione — DRG International, Inc. · Class I
- Androstenedione — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- Androstenedione-ELISA — Diasource Immunoassays, S.A. · Class I
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
- American Laboratory Products Company
Sources (1)
- FDA UDI 4585fc5a-e4a7-4c4a-990f-f3622ab31ead 36 fields · synced May 30, 2026