Identity
- Trade Name
- IMMULITE 2000 DHEAS Kit Domestic 200T FDA UDI
- Generic Name
- Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- IMMULITE 2000 DHEAS Kit Domestic 200T FDA UDI
- Model / Reference
- 10901849 FDA UDI
- Description
- IMMULITE 2000 DHEAS Kit Domestic 200T FDA UDI
Identifiers
- Catalog Number
- L2KDS2(D) FDA UDI
- Primary DI / UDI-DI
- 00630414167428 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
Yes
FDA UDI
Category: Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
IMMULITE 2000 DHEAS Kit Domestic 200T 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.
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- 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
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
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 50a409a3-1c2b-4195-95a2-e085f62fabb8 37 fields · synced Jun 1, 2026