Identity
- Trade Name
- IDS SHBG Calibration Verifiers FDA UDI
- Generic Name
- Sex hormone binding globulin (SHBG) IVD, calibrator FDA UDI
- Model / Reference
- IS-5635 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060169693708 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Sex hormone binding globulin (SHBG) IVD, calibrator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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: Sex hormone binding globulin (SHBG) IVD, calibrator
IDS SHBG Calibration Verifiers by Immunodiagnostic Systems , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sex hormone binding globulin (SHBG) IVD, calibrator.
- Atellica IM SHBG Calibrator — Siemens Healthcare Diagnostics · Class II
- ADVIA Centaur® CAL SHBG — Siemens Healthcare Diagnostics · Class II
- Elecsys SHBG CalSet — Roche Diagnostics Corp. · Class II
- Alinity — Abbott · Class II
- ARCHITECT — Abbott · Class II
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
- Immunodiagnostic Systems , Ltd.
Sources (1)
- FDA UDI 288ac7a7-d1ca-42f1-846f-d3ae8a8f7e24 34 fields · synced Jun 8, 2026