FDA Device Intelligence
Home › Device types › CGS

Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

FDA product code CGS · Class 2 · Clinical Chemistry

84
Registered devices
1,513
Adverse events
10
Recalls
123
510(k) clearances

Devices with this code

CK NAC — RANDOX LABORATORIES LIMITEDPOINTE SCIENTIFIC CK (Liquid) — HORIBA INSTRUMENTS INCORPORATEDCREATINE KINASE-SL — Sekisui Diagnostics, LLCCreatine Kinase liquid, acc. to IFCC — Roche Diagnostics GmbHCAROLINA LIQUID CHEMISTRIES CORP.® CK RGT. KIT AU-207 — CAROLINA LIQUID CHEMISTRIES CORPORATIONGENCHEM™ CK-NAC Reagent — GENCHEM INCACE — ALFA WASSERMANN, INC.Pointe Creatine Kinase for BS480 — HORIBA INSTRUMENTS INCORPORATEDSynermed® — INFRARED LABORATORY SYSTEMS LLCSynchron — Beckman Coulter, Inc.Creatine Kinase Assay — Sekisui Diagnostics, LLCABX PENTRA CK NAC CP — HORIBA ABX SASPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDPointe Scientific, Inc. Creatine Kinase — HORIBA INSTRUMENTS INCORPORATEDSynchron — Beckman Coulter, Inc.Teco Diagnostics Creatine Kinase (CK-NAC) Liquid Reagent — TECO DIAGNOSTICSIDG/Sanzay — IDG/SANZAY CorporationCK NAC — RANDOX LABORATORIES LIMITEDCK-MB — RANDOX LABORATORIES LIMITEDCK-NAC Reagent Set — CLINICAL DIAGNOSTIC SOLUTIONS, INC.Creatine Kinase liquid, acc. to IFCC — Roche Diagnostics GmbHCK-MB CONTROL — RANDOX LABORATORIES LIMITEDSPOTCHEM™ II CPK — ARKRAY USA, INC.Synermed® — INFRARED LABORATORY SYSTEMS LLC

Recent recalls

DateFirmReason
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.
2022-03-25Randox Laboratories Ltd.Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause a positive shift of approximately 6% with both Qual
2019-05-03Siemens Healthcare Diagnostics, Inc.A steady upward trend in blank (u) absorbance was observed
2019-05-03Siemens Healthcare Diagnostics, Inc.A steady upward trend in blank (u) absorbance was observed
2018-07-18Abbott Laboratories, IncThe product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results
2018-07-18Abbott Laboratories, IncThe product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results
2017-06-29Siemens Healthcare Diagnostics, Inc.Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine
2017-06-29Siemens Healthcare Diagnostics, Inc.Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine
2011-10-19Medtest Holdings, Inc.Linear performance information in product insert does not match that listed in the approved premarket notification
2007-10-12Abbott Laboratories Inc.Three potential issues with Creatine Kinase Lot Number: 52044HW00: (1) Decrease in quality control and/or patient results (2) An iIncreased imprecision, or (3

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.