Lowry (colorimetric), Total Protein
Clinical Chemistry · 21 CFR 862.1635
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- Ortho-Clinical DiagnosticsTerminatedNov 15, 2013
VITROS Chemistry Products UPRO Slides packaged as 90 slides/pack catalog number 6800120
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
Z-0327-2014 · View FDA record ↗ - Ortho-Clinical DiagnosticsTerminatedUnknown
VITROS Chemistry Products UPRO Slides, UPN 10758750000593,
There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides.
Z-1179-2017 · View FDA record ↗
Registered firms
11 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.
Rochester, NY, US
Biobase Biodustry(shandong)co., Ltd
Jinan Shandong, CN
Ortho Clinical Diagnostics
Singapore South West, SG
Wiener Laboratorios S.a.i.c.
ROSARIO Santa Fe, AR
Ortho-clinical Diagnostics European Support Center
Illkirch, CEDEX Bas-Rhin, FR
Ortho-clinical Diagnostics, Inc.
RARITAN, NJ, US
Bialex Lab
Wichita Falls, TX, US
Horiba Instruments Incorporated
Canton, MI, US
Ortho-clinical Diagnostics, Inc.
ROCHESTER, NY, US
510(k) clearances
5 clearances for this product code
- Pointe Scientific, Inc.,Dec 4, 2007
K070757 · MICROPROTEIN REAGENT SET
- Johnson & Johnson Clinical Diagnostics, Inc.Feb 18, 1997
K964960 · VITROS CHEMISTRY PRODUCTS UPRO SLIDES
- J. D. Assoc.Dec 10, 1986
K863112 · PROTEINMETER
- Biovation, Inc.Jun 10, 1982
K821534 · HEMATOLOGY DATA MANAGEMENT SYS
- Panmed, Inc.Dec 6, 1979
K792347 · MICRO LOWRY PROTEINTEST