Identity
- Trade Name
- Dehydroepiandrosterone (DHEA) ELISA FDA UDI
- Generic Name
- Dehydroepiandrosterone (DHEA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The DHEA ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of dehydroepiandrosterone (DHEA) in human serum and citrate plasma. For in vitro diagnostic use. FDA UDI
- Model / Reference
- 20-DHEHU-E01 FDA UDI
- Description
- The DHEA ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of dehydroepiandrosterone (DHEA) in human serum and citrate plasma. For in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 20-DHEHU-E01 FDA UDI
- Primary DI / UDI-DI
- B24220DHEHUE010 FDA UDI
- FDA Product Code
- JKC FDA UDI
- GMDN Term
- Dehydroepiandrosterone (DHEA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1245 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: Dehydroepiandrosterone (DHEA) IVD, kit, enzyme immunoassay (EIA)
Dehydroepiandrosterone (DHEA) ELISA by American Laboratory Products Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- DHEA-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 0ac79295-3e6f-4a2e-8d3e-7a24bac34c3b 36 fields · synced May 30, 2026