Identity
- Trade Name
- IMMULITE® 2000 Systems DHS DHEA-SO4 FDA UDI
- Generic Name
- Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- DHEA-S - IMMULITE - RGT - 200 Tests FDA UDI
- Model / Reference
- 10381193 FDA UDI
- Description
- DHEA-S - IMMULITE - RGT - 200 Tests FDA UDI
Identifiers
- Catalog Number
- L2KDS2 FDA UDI
- Primary DI / UDI-DI
- 00630414961309 FDA UDI
- 510(k) Number
- K935806 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
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
No
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 sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
IMMULITE® 2000 Systems DHS DHEA-SO4 by Siemens Healthcare Diagnostics Products Ltd — 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
- ARCHITECT — Abbott · Class I
- Elecsys DHEA-S — Roche Diagnostics Corp. · Class I
- DHEA-S ELISA — DRG International, Inc. · Class I
- DHEA-S ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- Atellica IM DHEAS — Siemens Healthcare Diagnostics · Class I
- ADVIA Centaur® DHEAS — Siemens Healthcare Diagnostics · Class I
Cleared under the same submission
K935806 also covers:
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
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 65c2e9bf-ca62-4034-a25b-1f9f35d55d6b 37 fields · synced May 30, 2026