Starch-dye Bound Polymer, Amylase
Clinical Chemistry · 21 CFR 862.1070
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
5 recall events for this product code
- Ortho-Clinical DiagnosticsTerminatedNov 15, 2013
VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 and packaged as 90 slides/pack catalog number 8112724
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
Z-0298-2014 · View FDA record ↗ - Ortho-Clinical DiagnosticsTerminatedUnknown
VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Product Usage:
Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.
Z-2364-2020 · View FDA record ↗ - Ortho-Clinical DiagnosticsTerminatedUnknown
VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Product Usage: For in vitro diagnostic use on
Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.
Z-2365-2020 · View FDA record ↗ - Ortho-Clinical DiagnosticsTerminatedUnknown
VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use only to quantitatively
Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.
Z-2366-2020 · View FDA record ↗ - Ortho-Clinical DiagnosticsTerminatedUnknown
VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - Product Usage: For in vitro diagnostic use only to quantitatively
Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.
Z-2367-2020 · View FDA record ↗
Registered firms
8 firms currently registered for this product code
Ortho Clinical Diagnostics, K.k.
Harumi, Chuo-ku Tokyo, JP
Ortho-clinical Diagnostics, Inc.
Rochester, NY, US
Ortho-clinical Diagnostics, Inc.
RARITAN, NJ, US
Ortho-clinical Diagnostics European Support Center
Illkirch, CEDEX Bas-Rhin, FR
Ortho-clinical Diagnostics, Inc.
ROCHESTER, NY, US
Ortho Clinical Diagnostics
Singapore South West, SG
Diafarma Ecza Deposu Ve Medikal Dis Ticaret Dis Tic Ltd Sti
Istanbul, TR
Beckman Coulter Ireland Inc
O CALLAGHANS MILLS Clare, IE
510(k) clearances
8 clearances for this product code
- Data Medical Associates, Inc.Oct 28, 1993
K931559 · DMA AMYLASE PROCEDURE
- Olympus Corp.Oct 19, 1992
K924339 · OLYMPUS AMYLASE REAGENT
- Em Diagnostic Systems, Inc.Jan 11, 1989
K884382 · AMYLASE TEST (AMYL) ITEM NUMBER: 65653
- Bio-Analytics Laboratories, Inc.Mar 5, 1985
K850639 · ENZYMATIC ALPHA-AMYLASE REAGENT KIT
- Eastman Kodak CompanyAug 3, 1981
K812027 · KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)
- Pharmacia, Inc.May 13, 1981
K810584 · PHADEBAS ISOAMYLASE TEST
- Calbiochem-Behring Corp.Mar 31, 1981
K810669 · PANTRAK E.K.
- Boehringer Mannheim Corp.Mar 2, 1979
K782032 · UNITEST AMYLASE