Identity
- Trade Name
- DHEA-S AccuLite CLIA Test System - 192 Wells FDA UDI
- Generic Name
- Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 5175-300 FDA UDI
Identifiers
- Catalog Number
- 5175-300B FDA UDI
- Primary DI / UDI-DI
- 00816870022789 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
No
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
Dimensions & Sizes
- Size
- Width — 7.75 Inch FDA UDI
Category: Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
DHEA-S AccuLite CLIA Test System - 192 Wells by Monobind, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- IMMULITE®/IMMULITE® 1000 Systems DHS DHEA-SO4 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
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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
- Monobind, Inc.
Sources (1)
- FDA UDI 9757e825-4853-44b6-b0eb-04f0d7dfe359 36 fields · synced Jun 8, 2026