Identity
- Trade Name
- Cortisol Saliva Luminescence Immunoassay FDA UDI
- Generic Name
- Free cortisol IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Cortisol Saliva Luminescence Immunoassay Assay Kit - 96 Determinations FDA UDI
- Model / Reference
- RE62111 FDA UDI
- Description
- Cortisol Saliva Luminescence Immunoassay Assay Kit - 96 Determinations FDA UDI
Identifiers
- Catalog Number
- RE62111 FDA UDI
- Primary DI / UDI-DI
- 04049325007727 FDA UDI
- FDA Product Code
- NHG FDA UDI
- GMDN Term
- Free cortisol IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1205 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
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: Free cortisol IVD, kit, chemiluminescent immunoassay
Cortisol Saliva Luminescence Immunoassay by IBL International GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Free cortisol IVD, kit, chemiluminescent immunoassay.
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 II | Pending data |
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Manufacturer
- Manufacturer
- IBL International GmbH
Sources (1)
- FDA UDI d2644c1d-cf66-449d-b28d-eed27851799c 36 fields · synced Jun 1, 2026