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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
QUALICHECK 4+, LEVEL 1 — Radiometer Medical ApSQUALICHECK 5+, LEVEL 1 — Radiometer Medical ApSBlood Gas and Electrolyte Control — Edan Instruments, Inc.STAT PROFILE — NOVA BIOMEDICAL CORPORATIONRANGE+ QUALICHECK LEV. 1 S7930 — Radiometer Medical ApSLiquichek — BIO-RAD LABORATORIES, INC.Blood Gas and Electrolyte Control — Edan Instruments, Inc.Stat Profile — NOVA BIOMEDICAL CORPORATIONSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONLipoprotein (a) Kit for use on SPAPLUS — THE BINDING SITE GROUP LIMITEDLiquichek — BIO-RAD LABORATORIES, INC.STAT PROFILE — NOVA BIOMEDICAL CORPORATIONDisposable Waste Container D512 REF 905-590 — Radiometer Medical ApSSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONLiquichek — BIO-RAD LABORATORIES, INC.S7745 AUTOCHECK TM 5+, LEVEL 2 — Radiometer Medical ApSCalibration Solution — Radiometer Medical ApSARCHITECT — ABBOTT LABORATORIESSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONContrIL Spectrum Control, Level 1 — INSTRUMENTATION LABORATORY COMPANYSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONPhoenix Diagnostics — PHOENIX DIAGNOSTICS, INC.VK-3 — RADIOMETER AMERICA INC.
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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