Home › Device types › CGA
Glucose Oxidase, Glucose
FDA product code CGA · Class 2 · Clinical Chemistry
1,084
Registered devices
7,674
Adverse events
89
Recalls
401
510(k) clearances
Devices with this code
CareTouch — Tianjin Empecs Medical Device Co.,LtdFORA — FORA CARE INC.STAT PROFILE — NOVA BIOMEDICAL CORPORATIONABL800 FLEX — Radiometer Medical ApSElectrode for ABL/BPH5 analyzers — Radiometer Medical ApSAUVON — UAN HEALTHCARE LIMITEDAUVON — Shenzhen Yuwen E-Commerce Co., Ltd.Enlite™ Serter — MEDTRONIC MINIMED, INC.Glucose LiquiColor® — STANBIO LABORATORY, L.P.YSI Incorporated — YSI INCORPORATEDPTS Panels® Glucose Test Strips (25-ct) — POLYMER TECHNOLOGY SYSTEMS, INC.Synermed® — INFRARED LABORATORY SYSTEMS LLCFORA — FORA CARE INC.i-STAT — ABBOTT POINT OF CARE INC.ABL80 SC80 — Radiometer Medical ApSPTS Panels® CHOL+HDL+GLU Test Strips (10-ct) + MeMoChip — POLYMER TECHNOLOGY SYSTEMS, INC.MEDLINE INDUSTRIES — MEDLINE INDUSTRIES, INC.AUVON — Shenzhen Yuwen E-Commerce Co., Ltd.Glucose Reagent — Diamond Diagnostics Inc.TysonBio AC200 Blood Glucose Test Strip, 10T — TYSON BIORESEARCH INC.Assure® Platinum BLOOD GLUCOSE TEST STRIPS — ARKRAY USA, INC.NOVA — NOVA BIOMEDICAL CORPORATIONGlucoLeader Enhance Blood Glucose Test Strip — HMD BIOMEDICAL INC.ABL80 SC80 — Radiometer Medical ApS
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-12 | HemoCue AB | Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. The affected |
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage con |
| 2024-03-01 | Alere San Diego, Inc. | There is a potential that the Cholestech LDX battery (an external battery pack available as an optional accessory to the Cholestech LDX Analyzer) may swell whic |
| 2023-09-06 | Randox Laboratories Ltd. | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below |
| 2023-09-06 | Randox Laboratories Ltd. | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below |
| 2023-09-06 | Randox Laboratories Ltd. | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below |
| 2022-08-16 | Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. | Incorrect instructions for use were packaged into the final product. |
| 2022-06-24 | Alere San Diego, Inc. | Cholesterol test cassettes package insert is to be updated with new bilirubin interference information because it was found that samples containing bilirubin, a |
| 2020-08-28 | Siemens Healthcare Diagnostics Inc | Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessa |
| 2019-09-18 | Medline Industries Inc | Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips. |
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