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Saccharogenic, Amylase

FDA product code CIJ · Class 2 · Clinical Chemistry

31

Registered devices

1

Adverse events

1

Recalls

31

510(k) clearances

Devices with this code

Pointe Scientific, Inc. Amylase — HORIBA INSTRUMENTS INCORPORATED Piccolo General Chemistry 13 — ABAXIS, INC.Amylase / BS200 — Medtest Dx, Inc.AMY — RANDOX LABORATORIES LIMITED AMY — RANDOX LABORATORIES LIMITED Amylase / BS480 — Medtest Dx, Inc.AMY — RANDOX LABORATORIES LIMITED POINTE SCIENTIFIC AMYLASE — HORIBA INSTRUMENTS INCORPORATED SPOTCHEM™ II ALP — ARKRAY USA, INC.Pointe Scientific, Inc. Amylase — HORIBA INSTRUMENTS INCORPORATED ClearChem Diagnostics Inc. Amylase — CLEARCHEM DIAGNOSTICS INC.Pointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATED Pointe Scientific — HORIBA INSTRUMENTS INCORPORATED Piccolo AmLyte 13 — ABAXIS, INC.SPOTCHEM™ II Creatinine — ARKRAY USA, INC.POINTE SCIENTIFIC Amylase — HORIBA INSTRUMENTS INCORPORATED Pointe Scientfic, Inc. — HORIBA INSTRUMENTS INCORPORATED POINTE SCIENTIFIC Amylase — HORIBA INSTRUMENTS INCORPORATED SPOTCHEM™ II Amylase — ARKRAY USA, INC.POINTE SCIENTIFIC AMYLASE — HORIBA INSTRUMENTS INCORPORATED AMY — RANDOX LABORATORIES LIMITED AMY — RANDOX LABORATORIES LIMITED POINTE SCIENTIFIC Amylase — HORIBA INSTRUMENTS INCORPORATED Piccolo BioChemistry Panel Plus — ABAXIS, INC.

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.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.