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Controls For Blood-Gases, (Assayed And Unassayed)
FDA product code JJS · Class 1 · Clinical Chemistry
142
Registered devices
3
Adverse events
1
Recalls
67
510(k) clearances
Devices with this code
STAT PROFILE — NOVA BIOMEDICAL CORPORATIONVK-3 — RADIOMETER AMERICA INC.S7765 AUTOCHECK TM 5+, LEVEL 4 — Radiometer Medical ApSSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONDisposable Waste Container D512 REF 905-590 — Radiometer Medical ApSPhoenix Diagnostics — PHOENIX DIAGNOSTICS, INC.Stat Profile — NOVA BIOMEDICAL CORPORATIONLiquichek — BIO-RAD LABORATORIES, INC.QUALICHECK 5+, LEVEL 1 — Radiometer Medical ApSHEMATOCRIT S7180 QC LEVEL 2 — Radiometer Medical ApSRAPIDQC® Plus Level 1 — Siemens Healthcare Diagnostics Inc.Stat Profile — NOVA BIOMEDICAL CORPORATIONSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONLiquichek — BIO-RAD LABORATORIES, INC.ARCHITECT — ABBOTT LABORATORIESS7755 AUTOCHECK TM 5+, LEVEL 3 — Radiometer Medical ApSMission Control, Level 1-2-3 — Diamond Diagnostics Inc.STAT PROFILE — NOVA BIOMEDICAL CORPORATIONRANGE+ QUALICHECK LEV. 1 S7930 — Radiometer Medical ApSPhoenix Diagnostics — PHOENIX DIAGNOSTICS, INC.QUALICHECK 5+, LEVEL 4 — Radiometer Medical ApSSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONAlinity — ABBOTT LABORATORIESARCHITECT — ABBOTT LABORATORIES
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-09-07 | Radiometer America Inc | Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2. A defective QC ampoule will |
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