Identity
- Trade Name
- DHEA-S ELISA FDA UDI
- Generic Name
- Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- For the direct quantitative determination of DHEAS by an enzyme immunoassay in human serum. FDA UDI
- Model / Reference
- CLA-4652 FDA UDI
- Description
- For the direct quantitative determination of DHEAS by an enzyme immunoassay in human serum. FDA UDI
Identifiers
- Catalog Number
- CLA-4652 FDA UDI
- Primary DI / UDI-DI
- 00840239046529 FDA UDI
- FDA Product Code
- JKC FDA UDI
- GMDN Term
- Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay 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
Yes
FDA UDI
Category: Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
Dhea-S Elisa by DRG International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay.
- Elecsys DHEA-S — Roche Diagnostics Corp. · Class I
- DHEA-S-RIA-CT — Diasource Immunoassays, S.A. · Class I
- IMMULITE 2000 DHEAS Kit Domestic 200T — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- ARCHITECT — Abbott · Class I
- Elecsys DHEA-S — Roche Diagnostics Corp. · Class I
- IMMULITE®/IMMULITE® 1000 Systems DHS DHEA-SO4 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- DHEA-S ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- Atellica IM DHEAS — Siemens Healthcare Diagnostics · 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
- DRG International, Inc.
Sources (1)
- FDA UDI 78a4ce07-43d5-4cf9-bc04-222927c5c840 36 fields · synced Jun 8, 2026