Reagent, Schiff
Hematology · 21 CFR 864.1850
Recent MDR events
3 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- EMD Millipore CorporationOpen, ClassifiedFeb 23, 2024
Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.
This IVD is colorless. A customer complaint was received noting it appeared pink. A review of inventory confirmed additional stock appeared pink.
Z-1185-2024 · View FDA record ↗ - EMD Chemicals IncTerminatedSep 20, 2008
Histochemical PAS (Periodic Acid Schiff) Reaction Set'
Two complaints that kit was not performing properly with positive controls.
Z-2303-2008 · View FDA record ↗
Registered firms
26 firms currently registered for this product code
Agilent Technologies Inc.
Cedar Creek, TX, US
Eng Scientific Llc
New Brunswick, NJ, US
Avantor Performance Materials, Llc
Paris, KY, US
Ricca Chemical Company Llc
ARLINGTON, TX, US
Celnovte Biotechnology Co., Ltd
zhengzhou Henan, CN
Merck Kgaa
DARMSTADT Hesse, DE
Chaptec America
Montreal Quebec, CA
Cancer Diagnostics, Inc.
Durham, NC, US
Transene Company, Inc.
DANVERS, MA, US
Ricca Chemical Company Llc
BATESVILLE, IN, US
E K Industries, Inc.
JOLIET, IL, US
Ethos Biosciences, Inc.
Logan Township, NJ, US
Slmp Llc D.b.a. Statlab Medical Products
McKinney, TX, US
Ventana Medical Systems, Inc.
Tucson, AZ, US
Richard-allan Scientific Llc
KALAMAZOO, MI, US
Sakura Finetek U.s.a., Inc.
TORRANCE, CA, US
Vwr Chemicals, Llc
Solon, OH, US
Azer Scientific, Inc.
Morgantown, PA, US
Medical Chemical Corporation
TORRANCE, CA, US
Ricca Chemical Company Llc
POCOMOKE CITY, MD, US
Agilent Technologies, Inc.
CARPINTERIA, CA, US
Biogenex Laboratories Inc.
Fremont, CA, US
Agilent Technologies, Inc
Santa Clara, CA, US
Volusol
Tooele, UT, US
Newcomer Supply Inc
Waunakee, WI, US
510(k) clearances
5 clearances for this product code
- Surgipath Medical Industries, Inc.Aug 5, 1988
K883217 · SCHIFF REAGENT
- Sigma Chemical Co.Oct 30, 1984
K843752 · SIGMA PERIODIC ACID-SCHIFF STAIN 395
- E K Ind., Inc.Sep 11, 1984
K842919 · SCHIFF REAGENT FUCHSIN-SULFUROUS ACID
- E K Ind., Inc.Sep 7, 1984
K842917 · SCHIFF REAGENT, PAS STAIN
- HarlecoJul 20, 1976
K760031 · HISTOCHEMICAL PAS REACTION SET