BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AZER SCIENTIFIC, INC.

    Reg #: 3009963993 · FEI: 3009963993 · Expires 2026
    View on FDA
    Products
    63
    Proprietary Names
    106
    Establishment Types
    5
    Classifications
    63

    Registration Details

    Registration Name
    AZER SCIENTIFIC, INC.
    Registration Number
    3009963993
    FEI Number
    3009963993
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    701 Hemlock Rd
    City
    Morgantown
    State
    PA
    ZIP
    19543
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191889

    Owner / Operator

    Firm Name
    Azer Scientific, LLC
    Operator Number
    9062234
    Address
    701 Hemlock Road, --
    City
    Morgantown
    State
    PA
    Postal Code
    19543
    Country
    US
    Correspondent
    Flip - Britton

    Products

    Device Name Product Code
    Giemsa Stain HYF
    Culture Media, Non-Propagating Transport JSM
    Microtome, Accessories IDL
    General Purpose Reagent PPM
    Container, Specimen Mailer And Storage, Non-Sterile NNK
    Dispensers, Paraffin IDW
    Diluent, Blood Cell GIF
    Device, Accessory, Cooling Plate For Tissue Embedding Station MXT
    Stains, Microbiologic JTS
    Reagent, Schiff HZT
    Formaldehyde (Formalin, Formol) IGG
    Formalin, Neutral Buffered IFP
    Device, Microtiter Diluting/Dispensing JTC
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Stains, Dye Solution LEE
    Container, Embedding KER
    Solution, Formalin-Sodium Acetate IGB
    Slide Stainer, Automated KPA
    Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates PTJ
    Polymer Patient Examination Glove LZA
    Hematoxylin HYJ
    Micro Pipette JRC
    Container, Specimen, Sterile FMH
    Mask, Surgical FXX
    Solution, Decalcifier, Acid Containing KDX
    Stains, Chemical Solution LED
    Hematoxylin Harris'S HYK
    Applicator, Absorbent Tipped, Sterile KXG
    Wright'S Stain IAF
    Mounting Media LEB
    Enzyme Immunoassay, Amphetamine DKZ
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Enzyme Immunoassay, Cannabinoids LDJ
    Fixative, Formalin-Containing LDY
    Microtome, Rotary IDO
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Infant Heel Warmer (Chemical Heat Pack) MPO
    Agent, Clearing KEM
    Eosin Y HYB
    Refrigerator, Freezer, Blood Storage KSE
    Coverslips, Microscope Slide KES
    Media, Mounting, Water Soluble KEQ
    Fast Green HYC
    Safranin HZS
    Stain, Papanicolau HZJ
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Slides, Microscope KEW
    Coronavirus Antigen Detection Test System. QKP
    Station, Pipetting And Diluting, For Clinical Use JQW
    Immunohistochemistry Reagents And Kits NJT
    Transport Medium, Notified Per The Vtm Guidance QMC
    Alcian Blue IDA
    Container, Sharps MMK
    Orange G HZH
    Container, Specimen, Non-Sterile NNI
    Stains, Hematology KQC
    Culture Media, Non-Selective And Non-Differential JSG
    Tube, Tissue Culture KJG
    Drink, Glucose Tolerance MRV
    Container, Specimen Mailer And Storage, Sterile KDT
    Iron Stains GGH
    Iodine, Grams HYI

    Proprietary Names

    Giemsa Stain Azer Scientific Universal Transport Medium (UTM) - PFUTM-10 High Profile Microtome Blades Trimming Blades Low Profile Microtome Blades Deionized water; reagent grade water; high purity water Biohazard transport bag AzerPath Embedding Center, AzerPath Embedding Center Hot Module Buffered Blood Bank Saline Blood Bank Saline with preservative Blood Bank Saline Non-Buffered Blood Bank Saline AzerPath Embedding Center, AzerPath Embedding Center Cold Plate Module Gram Decolorizer AFB Methylene Blue Crystal Violet Solution AFB Carbol Fuchsin AFB Kinyoun Reagent, Schiff 37% Formaldehyde 10% NBF AUTOPLAK Automated Plate Streaker GENERAL PURPOSE, LABELED OR PROMOTED FOR; SPECIMEN COLLECTION HOLDER Azer Tissue Marking Dye AzerPath Tissue Marking Dye Azer Mesh Cassette Azer Biopsy Cassette Azer Tissue Cassette SAF-FIXATIVE Fully Automatic IHC Stainer CNT320; Fully Automatic IHC Staining System CNT360-M1; Fully Automatic Immunohistochemistry NG-TEST® CARBA 5, for Detection of Five Bacterial Carbapenemase Enzyme TrueForm Vertex X6 Azer Nitrile Ultra Gloves Azer Gloves Standard Nitrile Azer Nitrile Plus Gloves Azer Nitrile Ultra Aloe Gloves TrueForm Everyday Nitrile TrueForm Extra Thin Nitrile Hematoxylin Clean Catch Kit Face Mask; Surgical Mask; Azer Surgical Mask; Azer Surgical Mask with Eye Shield; Azer Tie-Back Surgical Mask Solution, Decalcifier, Acid Containing Elite Acid Rinse 1 Hematoxylin Harris's Nasopharyngeal swab, Individually wrapped, sterile (ES45010) Specimen collection swab, individually wrapped, sterile (ES45013) Foam Swab, individually wrapped, sterile (ES45019S) Wright's Stain Fixative Mounting Media Drugs of abuse 12 in 1 test cup First Sign for Hemosure Formagel NG-TEST® CTX-M Multi, for Rapid ESBL Organism Detection Tube Vacutainer Azer Infant Heel Warmer Everclear Xylene Substitute D-Limonene Eosin Y Plasma Freezer Blood Bank Refrigerator Azer Cover Glass Media, Mounting, Water Soluble Fast Green Gram Stain Reagent, Safranin Papanicolaou Stain Easy Pap Stain Papanicolaou Stain Og-6 Spinplus Centrifuge Foam Swab, Bulk, Non-Sterile (ES45019) EVERMARK SELECT HISTOBOND UNIMARK AZERMARK EVERFROST EVERMARK UNIFROST Pipet tip for automation Acid-fast stain kit; ACTH (Polyclonal), RPab; Actin, Muscle Specific Actin (C8E11), MMab; Alcian Blue stain kit; ALK (5A Alcian blue BladeFLASK; Qlicksmart BladeFLASK; Qlicksmart Flask; Qlicksmart Scalpel Blade Remover Orange G Bouins Solution Alcoholic Formalin Saccomannos Fixative Hollandes Fixative Azer-5 Fixative Zinc Formalin Michels Fixative EasyFix™ Prefilled Reagent Alcohol FORMAGEL® Transport Tube, Non-sterile PRE-FILLED NEUTRAL BUFF Stains, Hematology Azer Scientific Sterile Buffered Saline (ES45044) Azer Scientific Sterile Saline (ES45045) Azer Sterile Saline (ES45049) Azer Sterile Buffered Saline (PBS) (ES45048) AZER CULTURE TUBE Simply Pure Glucose Drink Saliva Specimen Collection Device; Sterile Transport Tube Iron Stains Gram Stain Kit (Iodine)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility