Identity
- Trade Name
- Synermed® FDA UDI
- Generic Name
- Multiple-type clinical chemistry analyte profile IVD, calibrator FDA UDI
- Device Name
- ISE Calibrators and Controls 12 X 15 mL FDA UDI
- Model / Reference
- ISE530-K FDA UDI
- Description
- ISE Calibrators and Controls 12 X 15 mL FDA UDI
Identifiers
- Catalog Number
- ISE530-K FDA UDI
- Primary DI / UDI-DI
- 05060500091590 FDA UDI
- FDA Product Code
- JIX FDA UDI
- GMDN Term
- Multiple-type clinical chemistry analyte profile IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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
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: Multiple-type clinical chemistry analyte profile IVD, calibrator
Synermed® by Infrared Laboratory Systems Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Infrared Laboratory Systems Llc
Sources (1)
- FDA UDI aa34a59f-6d9f-49d4-87e6-5d542f4d91a7 36 fields · synced Jun 1, 2026