Identity
- Trade Name
- Free Testosterone ELISA FDA UDI
- Generic Name
- Free testosterone IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- For the direct quantitative determination of Free Testosterone by enzyme immunoassay in human serum. For in vitro diagnostic use only. FDA UDI
- Model / Reference
- EIA-4638 FDA UDI
- Description
- For the direct quantitative determination of Free Testosterone by enzyme immunoassay in human serum. For in vitro diagnostic use only. FDA UDI
Identifiers
- Catalog Number
- EIA-4638 FDA UDI
- Primary DI / UDI-DI
- 00840239046383 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Free testosterone IVD, kit, enzyme immunoassay (EIA)
Free Testosterone ELISA by DRG International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Free testosterone IVD, kit, enzyme immunoassay (EIA).
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class I
- Testosterone (Free) ELISA — IBL America · Class I
- AccuDiag ™ — Diagnostic Automation, Inc. · Class I
- Free Testosterone ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- Free Testosterone ELISA — American Laboratory Products Company · Class I
- Elecsys Testosterone II — Roche Diagnostics Corp. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DRG International, Inc.
Sources (1)
- FDA UDI b9f3e0fc-ba79-4302-8a62-295657709c3a 36 fields · synced Jun 8, 2026