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Catalytic Methods, Amylase
FDA product code JFJ · Class 2 · Clinical Chemistry
56
Registered devices
15
Adverse events
2
Recalls
99
510(k) clearances
Devices with this code
α – AMYLASE LIQUID REAGENT (KINETIC METHOD) TC MATRIX-240/480 — TECO DIAGNOSTICSAMY Reagent Kit — MEDICA CORPORATIONDimension Vista® Flex® reagent cartridge AMY — Siemens Healthcare Diagnostics Inc.Synchron — Beckman Coulter, Inc.CAROLINA LIQUID CHEMISTRIES CORP.® AMY REAGENT PRODUCT NO. DT227 — CAROLINA LIQUID CHEMISTRIES CORPORATIONAtellica CH PAmy — Siemens Healthcare Diagnostics Inc.Synermed® — INFRARED LABORATORY SYSTEMS LLCJAS Diagnostics — DREW SCIENTIFIC, INC.ARCHITECT — ABBOTT IRELANDJAS Diagnostics — DREW SCIENTIFIC, INC.P AMY — RANDOX LABORATORIES LIMITEDSirrus® Alpha-Amylase LiquiColor® — STANBIO LABORATORY, L.P.CAROLINA LIQUID CHEMISTRIES CORP.® AMY RGT. KIT BL-227 — CAROLINA LIQUID CHEMISTRIES CORPORATIONYumizen C1200 Amylase — HORIBA ABX SASa-Amylase EPS Pancreatic — Roche Diagnostics GmbHSynermed® — INFRARED LABORATORY SYSTEMS LLCalpha-Amylase EPS Pancreatic — Roche Diagnostics GmbHAmylase EPS ver2 — Roche Diagnostics GmbHADVIA® Chemistry PAMY Pancreatic Amylase Reagents — Siemens Healthcare Diagnostics Inc.CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 AMY RGT KIT Product No. ST227 — CAROLINA LIQUID CHEMISTRIES CORPORATIONSynermed® — INFRARED LABORATORY SYSTEMS LLCAMYLASE REAGENT SET (KINETIC METHOD) — TECO DIAGNOSTICSa-Amylase LiquiColor® — STANBIO LABORATORY, L.P.Liquid Select Amylase Reagent — Sekisui Diagnostics, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-07-10 | RANDOX LABORATORIES, LTD. | Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020. |
| 2007-12-03 | Roche Diagnostics Corp. | False Results- The reagent of the LDL-Cholesterol assay shows a carryover effect on the Lipase assay. Results may be falsely elevated by up to 50 units per lit |
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