Identity
- Trade Name
- GEM Premier 3000 BG HCT PAK (75 TEST) FDA UDI
- Generic Name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies FDA UDI
- Device Name
- GEM Premier 3000 3WK BG HCT PAK (75 TEST) FDA UDI
- Model / Reference
- 00024307504 FDA UDI
- Description
- GEM Premier 3000 3WK BG HCT PAK (75 TEST) FDA UDI
Identifiers
- Catalog Number
- 00024307504 FDA UDI
- Primary DI / UDI-DI
- 08426950087922 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
- Not 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
GEM Premier 3000 BG HCT PAK (75 TEST) by Instrumentation Laboratory Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 - 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 e14d4657-b8c9-4bc7-85f3-f1904a87eb41 38 fields · synced May 30, 2026