BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CalibreScientific US, Inc.

    Reg #: 2025606 · FEI: 2025606 · Expires 2026
    View on FDA
    Products
    32
    Proprietary Names
    60
    Establishment Types
    1
    Classifications
    32

    Registration Details

    Registration Name
    CalibreScientific US, Inc.
    Registration Number
    2025606
    FEI Number
    2025606
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1311 Se Cardinal Ct Ste 170
    City
    VANCOUVER
    State
    WA
    ZIP
    98683
    Country
    US

    Regulatory Submissions

    510(k) Number
    K881042

    Owner / Operator

    Firm Name
    CalibreScientific US, Inc.
    Operator Number
    2025606
    Address
    1311 SE Cardinal Ct, #170
    City
    Vancouver
    State
    WA
    Postal Code
    98683
    Country
    US
    Correspondent
    Robert Herrick

    Products

    Device Name Product Code
    Stains, Microbiologic JTS
    Slides, Microscope KEW
    Adhesive, Albumin-Based KEL
    Quality Control Slides LJG
    General Purpose Reagent PPM
    Fixative, Alcohol Containing LDZ
    Test, Leukocyte Peroxidase GIA
    Hematoxylin HYJ
    Material, Quality Control, Semen Analysis NRF
    Stains, Chemical Solution LED
    Sudan Iii KKJ
    Supplement, Culture Media JSK
    Ph Buffer JCC
    Carbol Fuchsin ICL
    Clinical Sample Concentrator JJH
    Acridine Orange IDC
    Aniline Blue KFD
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Reagents, Specific, Analyte MVU
    Sperm, Antigen, Antiserum, Control DFQ
    Sudan Iv KKK
    Culture Media, Selective And Non-Differential JSJ
    Auramine O KJK
    Device, Parasite Concentration LKS
    Giemsa Stain HYF
    Brilliant Green KJO
    Formalin, Neutral Buffered IFP
    Container, Specimen Mailer And Storage, Non-Sterile NNK
    Kit, Identification, Mycobacteria JSY
    Agent, Clearing KEM
    Solution, Formalin-Sodium Acetate IGB
    Container, Specimen Mailer And Storage, Sterile KDT

    Proprietary Names

    Trichrome Stain CELL-BOND(TM) Slide Coating Solution AFB Stain QC Slides CONSED(TM) MYCO-PAC(TM) MUCOSOL(TM) CONSED RED(TM) PROTO-FIX (TM) Mayer's Albumin LeucoScreen™ Hematoxylin Mordant Hematoxylin Stain QC-Beads™ Trichrome-Plus(TM) SUDAN III M/15 Phosphate Buffer Product PRB(TM) Pellet Resuspension Buffer NPC-67(TM) XPR-PLUS(TM) TB Rapid Stain Set PRS(TM) Parasite Recovery System Cryptosporidium Stain Set PHENOLIC ACRIDINE ORANGE STAIN PVA Fixative Solution Lactophenol Aniline Blue Centrifuge Tubes FructoScreen® CitricScreen® MarScreen® IgA, IgG, IgM Sperm Antibody A/G Serum Controls ImmunoSpheres®Anti-IgA, Anti-IgG, Anti-IgM, Anti-Ig(H&L) SUDAN IV ETM(TM) Auramine O PARA-PRO(TM) fc50 GIEMSA STAIN Kinyoun Carbolfuchsin Ziehl-Neelsen Carbolfuchsin TB BILLIANT GREEN Gram Stain Set Formalin 10% Buffered Formalin 5% Buffered Clean Collection Vial Parasitology Stain QC Slide Malaria QC Slide 0.2% Bovine Albumin Fraction V Solu Carbol PRO-Clear(TM) ESC-1(TM) Carbol-Xylene Xylene PRO-Clear(TM) Cryptosporodium Stain QC Slide SAF FIXATIVE Nocardia Stain QC Slides Gram Stain QC Slide NAC-PAC(TM) NAC-PAC RED (TM) TRITON2(tm) OxA(tm)

    Establishment Types

    Manufacture Medical Device