Identity
- Trade Name
- Testosterone (Free) ELISA FDA UDI
- Generic Name
- Free testosterone IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Enzyme immunoassay (ELISA) for the direct quantitative determination of Free Testosterone in human serum. FDA UDI
- Model / Reference
- IB59109 FDA UDI
- Description
- Enzyme immunoassay (ELISA) for the direct quantitative determination of Free Testosterone in human serum. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B652IB59109 FDA UDI
- FDA Product Code
- CDZ FDA UDI
- GMDN Term
- Free testosterone IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1680 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Free testosterone IVD, kit, enzyme immunoassay (EIA)
Testosterone (Free) ELISA by IBL America — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Free testosterone IVD, kit, enzyme immunoassay (EIA).
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- Elecsys Testosterone II — Roche Diagnostics Corp. · Class I
- Free Testosterone ELISA — DRG International, Inc. · Class I
- DBC Free Testosterone ELISA — Diagnostics Biochem Canada Inc · Class I
- Free Testosterone ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · 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
- IBL America
Sources (1)
- FDA UDI 240c3227-11b1-4170-9cc9-42f07c2e3fe0 35 fields · synced May 30, 2026