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Catalytic Methods, Amylase
FDA product code JFJ · Class 2 · Clinical Chemistry
56
Registered devices
13
Adverse events
2
Recalls
99
510(k) clearances
Devices with this code
Synermed® — INFRARED LABORATORY SYSTEMS LLCADVIA® Chemistry PAMY Pancreatic Amylase Reagents — Siemens Healthcare Diagnostics Inc.Synermed® — INFRARED LABORATORY SYSTEMS LLCCAROLINA LIQUID CHEMISTRIES CORP.® AMY REAGENT PRODUCT NO. DT227 — CAROLINA LIQUID CHEMISTRIES CORPORATIONARCHITECT — Abbott GmbHSynchron — Beckman Coulter, Inc.CAROLINA LIQUID CHEMISTRIES CORP.™ AMY AMYLASE REAGENT CC227 — CAROLINA LIQUID CHEMISTRIES CORPORATIONalpha-Amylase EPS Pancreatic — Roche Diagnostics GmbHThermo Scientific Infinity™ — Fisher DiagnosticsSynermed® — INFRARED LABORATORY SYSTEMS LLCCAROLINA LIQUID CHEMISTRIES CORP.® CLC720 AMY RGT KIT Product No. ST227 — CAROLINA LIQUID CHEMISTRIES CORPORATIONDimension Vista® Flex® reagent cartridge AMY — Siemens Healthcare Diagnostics Inc.Amylase EPS ver2 — Roche Diagnostics GmbHSynermed® — INFRARED LABORATORY SYSTEMS LLCPancreatic Amylase — SENTINEL CH. SPAAtellica CH AMY_2 — Siemens Healthcare Diagnostics Inc.α – AMYLASE LIQUID REAGENT (KINETIC METHOD) — TECO DIAGNOSTICSJAS Diagnostics — DREW SCIENTIFIC, INC.α – AMYLASE LIQUID REAGENT (KINETIC METHOD) TC MATRIX-240/480 — TECO DIAGNOSTICSJAS Diagnostics — DREW SCIENTIFIC, INC.JAS Diagnostics — DREW SCIENTIFIC, INC.JAS Diagnostics — DREW SCIENTIFIC, INC.JAS Diagnostics — DREW SCIENTIFIC, INC.AMY Reagent Kit — MEDICA CORPORATION
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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