Identity
- Trade Name
- Androstenedione-ELISA FDA UDI
- Generic Name
- Androstenedione IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Androstenedione-ELISA FDA UDI
- Model / Reference
- KAPD3265 FDA UDI
- Description
- Androstenedione-ELISA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05400569000865 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Androstenedione IVD, kit, enzyme immunoassay (EIA)
Androstenedione-ELISA by Diasource Immunoassays, S.A. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Androstenedione IVD, kit, enzyme immunoassay (EIA).
- Androstenedione ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
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- ANST AccuBind ELISA Test System - 192 Wells — MONOBIND, INC. · Class I
- ANST AccuLite CLIA Test System - 192 Wells — MONOBIND, INC. · Class I
- Androstenedione — DRG International, Inc. · Class I
- Androstenedione — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- ANST AccuBind ELISA Test System - 96 Wells — MONOBIND, INC. · 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
- Diasource Immunoassays, S.A.
Sources (1)
- FDA UDI 75c7e4e2-a512-4300-8539-d13806f877d9 33 fields · synced May 30, 2026