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
Pointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDCK Liqui-UV® — STANBIO LABORATORY, L.P.CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 CK RGT KIT Product No. ST207 — CAROLINA LIQUID CHEMISTRIES CORPORATIONCAROLINA LIQUID CHEMISTRIES CORP.® CK REAGENT PRODUCT NO. DT207 — CAROLINA LIQUID CHEMISTRIES CORPORATIONSynermed® — INFRARED LABORATORY SYSTEMS LLCSynermed® — INFRARED LABORATORY SYSTEMS LLCCK — HORIBA INSTRUMENTS INCORPORATEDCK NAC — RANDOX LABORATORIES LIMITEDCAROLINA LIQUID CHEMISTRIES CORP.® CKMB CC692 — CAROLINA LIQUID CHEMISTRIES CORPORATIONARCHITECT — Abbott GmbHCK — RANDOX LABORATORIES LIMITEDJAS Diagnostics — DREW SCIENTIFIC, INC.Synermed® — INFRARED LABORATORY SYSTEMS LLCCK-MB CONTROL — RANDOX LABORATORIES LIMITEDADVIA® Chemistry CKNAC Creatine Kinase Reagents — Siemens Healthcare Diagnostics Inc.IDG/Sanzay — IDG/SANZAY CorporationAU — Beckman Coulter, Inc.Yumizen C1200 CK-NAC — HORIBA ABX SASJAS Diagnostics — DREW SCIENTIFIC, INC.Pointe Scientific, Inc. CK — HORIBA INSTRUMENTS INCORPORATEDCREATINE KINASE-SL — SEKISUI DIAGNOSTICS, LLCDimension® Flex® reagent cartridge MBI — Siemens Healthcare Diagnostics Inc.Teco Diagnostics Creatine Kinase (CK-NAC) Reagent Set — TECO DIAGNOSTICSCK-MB — RANDOX LABORATORIES LIMITED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2022-03-25 | Randox 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 |
| 2019-05-03 | Siemens Healthcare Diagnostics, Inc. | A steady upward trend in blank (u) absorbance was observed |
| 2019-05-03 | Siemens Healthcare Diagnostics, Inc. | A steady upward trend in blank (u) absorbance was observed |
| 2018-07-18 | Abbott Laboratories, Inc | The 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 |
| 2018-07-18 | Abbott Laboratories, Inc | The 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 |
| 2017-06-29 | Siemens 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 |
| 2017-06-29 | Siemens 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 |
| 2011-10-19 | Medtest Holdings, Inc. | Linear performance information in product insert does not match that listed in the approved premarket notification |
| 2007-10-12 | Abbott 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 |
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