MERCK KGAA

FDA Device Registration & Listing · DARMSTADT Hesse, DE · Registration 9610140

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9610140
FEI Number
3002806906
Entity Name
MERCK KGAA
City/State/Country
DARMSTADT Hesse, DE
Establishment Address
250 FRANKFURTER STRASSE, DARMSTADT Hesse 64271, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Merck Life Science KGaA (Owner Number: 8010686)
Owner / Operator Contact Address
Frankfurter Strasse 250, Darmstadt, DE-HE 64293, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

MAYER'S HEMALUM SOLUTION FOR MICROSCOPY TETRAZOLIUM BLUE FOR MICROSCOPY METHYL BLUE (C.I. 42780) FOR MICROSCOPY NITRO BLUE TETRAZOLIUM CHLORIDE (NBT) FOR MICROSCOPY AMIDO BLACK 10 B (C.I. 20470) FOR ELECTROPHORESIS PARAROSANILINE (CHLORIDE) (C.I. 42500) FOR MICROSCOPY CERTISTAIN NILE BLUE (HYDROGEN SULFATE) (C.I. 51180) FOR MICROSCOPY CERTISTAIN PHLOXIN B (C.I. 45410) FOR MICROSCOPY CERTISTAIN CRESYL VIOLET (ACETATE) FOR MICROSCOPY CERTISTAIN RHODAMINE B (C.I. 45170) FOR MICROSCOPY FLUORESCEIN-5-ISOTHIOCYANATE (FITC) FOR BIOCHEMISTRY AND FOR FLUORESCENCE MICROSCOPY PONCEAU S (C.I. 27195) FOR MICROSCOPY CERTISTAIN LOEFFLER'S METHYLENE BLUE SOLUTION FOR MICROSCOPY METHYLENE BLUE (C.I. 52015) FOR MICROSCOPY CERTISTAIN IMMERSION OIL FOR MICROSCOPY KAISER'S GLYCEROL GELATINE, PHENOL-FREE FOR MICROSCOPY AQUATEX ® (AQUEOUS MOUNTING AGENT) FOR MICROSCOPY Neo-MountTM anhydrous mounting medium for microscopy KAISER'S GLYCEROL GELATINE FOR MICROSCOPY BUFFER TABLETS PH 7.2 FOR PREPARING BUFFER SOLUTION ACC. TO WEISE FOR STAINING OF BLOOD SMEARS BUFFER TABLETS PH 6.8 FOR PREPARING BUFFER SOLUTION ACC. TO WEISE FOR THE STAINING OF BLOOD SMEARS BUFFER TABLETS PH 6.4 FOR PREPARING BUFFER SOLUTION ACC. TO WEISE FOR THE STAINING OF BLOOD SMEARS METHYL GREEN ZINC CHLORIDE DOUBLE SALT (C.I. 42590) FOR MICROSCOPY CERTISTAIN ACRIDINE ORANGE ZINC CHLORIDE DOUBLE SALT (C.I.46005) FOR MICROSCOPY CERTISTAIN LUGOL'S SOLUTION (DILUTED IODINE-POTASSIUM IODIDE SOLUTION) FOR THE GRAM STAINING METHOD HEMATOGNOST FE STAINING KIT FOR THE DETECTION OF FREE IONIC IRON (FE3+) IN CELLS THIONINE (ACETATE) (C.I. 52000) FOR MICROSCOPY CERTISTAIN BRILLIANT CRESYL BLUE SOLUTION FOR THE STAINING OF RETICULOCYTES FOR MICROSCOPY BRILLIANT CRESYL BLUE ZINC CHLORIDE DOUBLE SALT FOR MICROSCOPY CERTISTAIN HEMACOLOR RAPID STAINING OF BLOOD SMEAR SOLUTION 3 COLOUR REAGENT BLUE MAY-GRUENWALD'S EOSINE-METHYLENE BLUE SOLUTION MODIFIED FOR MICROSCOPY HEMACOLOR RAPID STAINING OF BLOOD SMEAR SOLUTION 1 FIXING SOLUTION LEISHMAN'S EOSIN METHYLENE BLUE SOLUTION MODIFIED FOR MICROSCOPY HEMACOLOR RAPID STAINING OF BLOOD SMEAR SOLUTION 2 COLOUR REAGENT RED TUERK'S SOLUTION FOR LEUKOCYTE COUNTING LEUCOGNOST MIXTURE OF FIXATIVES FIXATIVE FOR ENZYME CYTOCHEMISTRY LEISHMAN'S EOSINE METHYLENE BLUE FOR MICROSCOPY HEMACOLOR RAPID STAINING OF BLOOD SMEAR STAINING SET FOR MICROSCOPY MAY-GRUENWALD'S EOSIN METHYLENE BLUE FOR MICROSCOPY CARMINE (C.I. 75470) (CALCIUM-ALUMINIUM LACQUER OF CARMINIC ACID) FOR MICROSCOPY CERTISTAIN CARMINIC ACID (C.I. 75470) GR FOR ANALYSIS AND FOR MICROSCOPY GIEMSA'S AZUR-EOSIN-METHYLENE BLUE FOR MICROSCOPY AZURE II (C.I. 52010/52015) FOR MICROSCOPY GIEMSA'S AZUR EOSIN METHYLENE BLUE SOLUTION FOR MICROSCOPY LUGOL'S SOLUTION STABILIZED WITH PVP FOR THE GRAM STAINING RETICULIN SILVER PLATING KIT ACC. TO GORDON & SWEETS RETICULIN SILVER PLATING KIT ACC. TO GORDON & SWEETS SILVER PLATING KIT ACC. TO VON KOSSA FOR MICROSCOPY WARTHIN-STARRY SILVER PLATING KIT MODIFIED FOR DETECTION OF HELICOBACTER PYLORI AND SPIROCHETES IN PARAFFIN SECTIONS ORCEIN FOR MICROSCOPY CERTISTAIN PAPANICOLAOU'S SOLUTION 2B ORANGE II SOLUTION FOR CYTOLOGY METHENAMINE SILVER PLATING KIT ACC. TO GOMORI FOR MICROSCOPY ALCIAN BLUE SOLUTION FOR MICROSCOPY Alcian blue staining kit, pH 2.5 ALCIAN BLUE 8 GX (C.I.74240) FOR MICROSCOPY CERTISTAIN LEUCOGNOST MIXTURE OF FIXATIVES FIXATIVE FOR ENZYME CYTOCHEMISTRY ImmunoCard STAT! EHEC LACTOPHENOL BLUE SOLUTION FOR STAINING FUNGI GRAM-COLOR MODIFIED (PHENOL-FREE) STAINING KIT FOR GRAM STAINING METHOD ON BACTERIOLOGICAL SMEARS AFB-FLUOR PHENOL-FREE STAINING KIT FOR THE ACID-FAST SMEAR EXAMINATION WITH FLUORESCENCE MICROSCOPY GRAM-COLOR STAIN SET FOR THE GRAM STAINING METHOD AFB-FLUOR STAINING KIT FOR FLUORESCENCE-MICROSCOPIC DETECTION OF ACID FAST BACTERIA WRIGHT'S EOSINE METHYLENE BLUE FOR MICROSCOPY WRIGHT'S EOSIN METHYLENE BLUE SOLUTION FOR MICROSCOPY ImmunoCard STAT! CAMPY GLUTARDIALDEHYDE SOLUTION 25% FOR ELECTRON MICROSCOPY, ACC. TO P.J. ANDERSON AFB-COLOR CARBOL FUCHSIN SOLUTION FOR THE MICROSCOPIC INVESTIGATION OF ACID-FAST BACTERIA (AFB) (COLD STAINING) ZIEHL-NEELSEN CARBOL-FUCHSIN SOLUTION FOR MICROSCOPY AFB staining kit for histology for the detection of acid-fast bacteria in histological tissue AFB-COLOR STAINING KIT FOR THE MICROSCOPIC INVESTIGATION OF OF ACID-FAST BACTERIA (AFB) (COLD STAINING) EOSIN Y-SOLUTION 0.5% AQUEOUS FOR MICROSCOPY EOSIN Y-SOLUTION 0.5% ALCOHOLIC FOR MICROSCOPY EOSIN Y (YELLOWISH) (C.I. 45380) FOR MICROSCOPY CERTISTAIN EOSIN Y SOLUTION 1 % ALCOHOLIC PAPANICOLAOU'S SOLUTION 2A ORANGE G SOLUTION (OG 6) FOR CYTOLOGY ORANGE G (C.I. 16230) FOR MICROSCOPY CERTISTAIN FUCHSIN ACID (C.I. 42685) FOR MICROSCOPY CERTISTAIN Schiff's Reagent Intense SCHIFF'S REAGENT FOR MICROSCOPY PAS STAINING KIT FOR DETECTION OF ALDEHYDE AND MUCOSUBSTANCES NUCLEAR FAST RED (C.I. 60760) FOR MICROSCOPY CERTISTAIN NUCLEAR FAST RED-ALUMINUM SULFATE SOLUTION 0.1% FOR MICROSCOPY HISTOSEC PASTILLES (WITHOUT DMSO) SOLIDIFICATION POINT 56-58 GRAD C EMBEDDING AGENT FOR HISTOLOGY HISTOSEC PASTILLES SOLIDIFICATION POINT 56-58 GRAD C EMBEDDING AGENT FOR HISTOLOGY PARAFFIN PASTILLES SOLIDIFICATION POINT ABOUT 56-58 GRAD C FOR HISTOLOGY AURAMINE O (C.I. 41000) FOR MICROSCOPY MALACHITE GREEN OXALATE (C.I. 42000) FOR MICROSCOPY AND FOR MICROBIOLOGY AFB-COLOR MALACHITE GREEN (OXALATE) SOLUTION FOR THE MICROSCOPIC INVESTIGATION OF ACID-FAST BACTERIA (COLD STAINING) MALACHITE GREEN OXALATE (C.I. 42000) FOR MICROSCOPY CERTISTAIN EOSIN B (BLUISH) (C.I.45400) FOR MICROSCOPY CERTISTAIN PICROFUCHSIN SOLUTION ACC. TO VAN GIESON FOR MICROSCOPY FORMALDEHYDE SOLUTION 4% BUFFERED (PH 6.9), FOR HISTOLOGY WEIGERT'S IRON HEMATOXYLIN KIT FOR NUCLEAR STAINING IN HISTOLOGY CRYSTAL VIOLET (C.I. 42555) FOR MICROSCOPY CERTISTAIN GRAM'S CRYSTAL VIOLET SOLUTION FOR THE GRAM STAINING METHOD PAPANICOLAOU'S SOLUTION 3D POLYCHROMATIC SOLUTION EA 65 FOR CYTOLOGY PAPANICOLAOU'S SOLUTION 3A POLYCHROMATIC SOLUTION EA 31 FOR CYTOLOGY SHORR STAINING SOLUTION FOR HORMONAL CYTODIAGNOSIS PAPANICOLAOU'S SOLUTION 3B POLYCHROMATIC SOLUTION EA 50 FOR CYTOLOGY SAFRANINE O (C.I. 50240) FOR MICROSCOPY CERTISTAIN GRAM'S SAFRANINE SOLUTION FOR THE GRAM STAINING METHOD OSMIUM(VIII) OXIDE FOR MICROSCOPY OSTEOMOLL SOLUTION FOR RAPID DECALCIFICATION (WITH FIXATION) FOR HISTOLOGY ELASTICA VAN GIESON STAINING KIT FOR CONNECTIVE TISSUE M-GLAS¿ LIQUID COVER GLASS FOR MICROSCOPY ENTELLAN NEW RAPID MOUNTING MEDIUM FOR MICROSCOPY DPX NON-AQUEOUS MOUNTING MEDIUM FOR MICROSCOPY CANADA BALSAM FOR MICROSCOPY ENTELLAN RAPID MOUNTING MEDIUM FOR MICROSCOPY ENTELLAN NEW FOR COVER SLIPPER FOR MICROSCOPY DPX NEW WATER-FREE MOUNTING MEDIUM OSTEOSOFT MILD DECALCIFIER-SOLUTION FOR HISTOLOGY

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HYL Hematoxylin Mayer'S Hematology Class 1 864.1850 2001-08-06
LEF Stains, Dye Powder Hematology Class 1 864.1850 2001-08-06
HZO Stain, Ponceau Hematology Class 1 864.1850 1984-08-15
KFC Methylene Blue, Tissue Stain Hematology Class 1 864.1850 1984-08-15
IJZ Oil, Clearing Pathology Class 1 864.4010 1978-02-09
KEQ Media, Mounting, Water Soluble Pathology Class 1 864.4010 2013-07-09
JCC Ph Buffer Pathology Class 1 864.4010 2010-06-30
HZA Methyl Green Hematology Class 1 864.1850 1984-08-15
IDC Acridine Orange Hematology Class 1 864.1850 1986-12-31
IAM Solution, Lugol'S Pathology Class 1 864.4010 2001-08-06
GGH Iron Stains Hematology Class 1 864.1850 1984-08-15
KKL Thionin Hematology Class 1 864.1850 2013-07-03
KJN Brilliant Cresyl Blue Hematology Class 1 864.1850 1984-08-15
KQC Stains, Hematology Hematology Class 1 864.1850 2001-08-06
KJP Carmine Hematology Class 1 864.1850 2013-07-09
HYF Giemsa Stain Hematology Class 1 864.1850 1984-08-15
HYI Iodine, Grams Hematology Class 1 864.1850 1984-08-15
HZY Sirius Red Hematology Class 1 864.1850 2013-07-02
HZX Silver Nitrate Hematology Class 1 864.1850 2013-07-02
KKF Orcein Hematology Class 1 864.1850 2010-09-03
KKE Orange Ii Hematology Class 1 864.1850 2013-07-08
HYZ Methenamine Silver Hematology Class 1 864.1850 2013-07-02
IDA Alcian Blue Hematology Class 1 864.1850 2010-09-03
IGF Solution, Formalin-Alcohol-Acetic Acid Pathology Class 1 864.4010 2013-07-08
GMZ Antigens, All Types, Escherichia Coli Microbiology Class 1 866.3255 2023-10-23
JTS Stains, Microbiologic Hematology Class 1 864.1850 1984-08-15
IAF Wright'S Stain Hematology Class 1 864.1850 1984-08-15
LQP Campylobacter Spp. Microbiology Class 1 866.3110 2009-06-03
IFT Glutaraldehyde Pathology Class 1 864.4010 1978-02-09
ICL Carbol Fuchsin Hematology Class 1 864.1850 1984-08-15
HYB Eosin Y Hematology Class 1 864.1850 1978-02-09
HZH Orange G Hematology Class 1 864.1850 1984-08-15
IDF Acid, Fuchsin Hematology Class 1 864.1850 1978-02-07
HZT Reagent, Schiff Hematology Class 1 864.1850 1984-08-15
HZF Nuclear Fast Red Hematology Class 1 864.1850 1984-12-17
KEO Formulations, Paraffin, All Pathology Class 1 864.4010 2006-02-28
KJK Auramine O Hematology Class 1 864.1850 2013-07-09
KJY Malachite Green Hematology Class 1 864.1850 2010-08-19
ICC Eosin B Hematology Class 1 864.1850 1984-08-15
IAD Van Gieson'S Picro-Fuchsin Hematology Class 1 864.1850 2013-07-02
IFP Formalin, Neutral Buffered Pathology Class 1 864.4010 1984-08-15
HYO Hematoxylin Weigert'S Hematology Class 1 864.1850 1984-08-15
ICF Crystal Violet For Histology Hematology Class 1 864.1850 1984-08-15
HZJ Stain, Papanicolau Hematology Class 1 864.1850 1984-08-15
HZS Safranin Hematology Class 1 864.1850 1978-02-09
KEE Osmium Tetroxide Pathology Class 1 864.4010 2013-07-09
KDX Solution, Decalcifier, Acid Containing Pathology Class 1 864.4010 2013-07-08
IAC Van Gieson'S Stain Hematology Class 1 864.1850 2013-07-02
KEP Media, Mounting, Oil Soluble Pathology Class 1 864.4010 2013-07-09
KDY Agent, Chelating For Decalcification Pathology Class 1 864.4010 1989-07-27

Official Correspondent

No official correspondent registered.

US Agent Details

Catherine Karaman Business: MilliporeSigma Email: catherine.karaman@milliporesigma.com Phone: (951) 5144240

Related Public Records

Same Entity

Merck Life Science KGaA
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K791007 Bioscientific STAT DIFF STAIN 1979-08-03
K821443 Lerner Laboratories, Inc. FORMICAL 1982-06-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0043-2012 EMD Chemicals Inc. 1
Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals Inc., Gibbstown, NJ 08027 1-800-222-0342 Made in India. The product is a Class I, IVD dye and chemical stain for use in Hematology.
Z-0025-05 Becton Dickinson & Co. 1
Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8 L bottles, catalog # 212526, staining reagent.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610140. Last updated year: 2026. Please use registration number 9610140 when referencing this establishment in official correspondence.
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