Identity
- Trade Name
- GEM Premier 3000 iQM - BG HCT - 75 Tests FDA UDI
- Generic Name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies FDA UDI
- Device Name
- GEM Premier 3000 iQM 4WK - BG HCT - 75 Tests FDA UDI
- Model / Reference
- 00024407584 FDA UDI
- Description
- GEM Premier 3000 iQM 4WK - BG HCT - 75 Tests FDA UDI
Identifiers
- Catalog Number
- 00024407584 FDA UDI
- Primary DI / UDI-DI
- 08426950088189 FDA UDI
- 510(k) Number
- K052121 FDA UDI
- FDA Product Code
- CHL FDA UDI
- GMDN Term
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1120 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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 3000 iQM - BG HCT - 75 Tests by Instrumentation Laboratory Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K052121 also covers:
- GEM CVP (Calibration Validation Product) — INSTRUMENTATION LABORATORY COMPANY
- GEM CVP (Calibration Validation Product) Level 1 — INSTRUMENTATION LABORATORY COMPANY
- GEM CVP (Calibration Validation Product) Level 2 — INSTRUMENTATION LABORATORY COMPANY
- GEM CVP (Calibration Validation Product) Level 3 — INSTRUMENTATION LABORATORY COMPANY
- GEM CVP (Calibration Validation Product) Level 4 — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 3000 iQM - BG HCT - 150 Tests — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 3000 iQM - BG HCT - 300 Tests — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 3000 iQM - BG HCT - 35 Tests — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 3000 iQM - BG HCT - 450 Tests — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 3000 iQM - BG HCT - 600 Tests — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 3000 iQM - BG HCT - 75 Tests — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 3000 iQM - BG HCT ELECT - 75 Tests — INSTRUMENTATION LABORATORY COMPANY
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
- Instrumentation Laboratory Company
Sources (1)
- FDA UDI 4a13e3bf-6d52-41ed-a75e-c3e917cf4f5b 37 fields · synced May 30, 2026