Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2025606

FEI Number

2025606

Entity Name

CalibreScientific US, Inc.

City/State/Country

VANCOUVER, WA, US

Establishment Address

1311 Se Cardinal Ct Ste 170, VANCOUVER, WA 98683, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CalibreScientific US, Inc. (Owner Number: 2025606)

Owner / Operator Contact Address

1311 SE Cardinal Ct, #170, Vancouver, WA 98683, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K880990

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JTS	Stains, Microbiologic	Hematology	Class 1	864.1850	2009-04-14
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2013-08-22
KEL	Adhesive, Albumin-Based	Pathology	Class 1	864.4010	2001-11-19
LJG	Quality Control Slides	Microbiology	Class 1	866.2660	2009-04-14
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2001-11-19
LDZ	Fixative, Alcohol Containing	Pathology	Class 1	864.4010	2007-02-07
KEL	Adhesive, Albumin-Based	Pathology	Class 1	864.4010	2009-04-14
GIA	Test, Leukocyte Peroxidase	Hematology	Class 1	864.7675	2024-06-03
HYJ	Hematoxylin	Hematology	Class 1	864.1850	2012-01-27
NRF	Material, Quality Control, Semen Analysis	Hematology	Class 2	864.8625	2024-06-03
LED	Stains, Chemical Solution	Hematology	Class 1	864.1850	2007-02-07
KKJ	Sudan Iii	Hematology	Class 1	864.1850	2007-02-07
JSK	Supplement, Culture Media	Microbiology	Class 1	866.2450	2009-04-14
JCC	Ph Buffer	Pathology	Class 1	864.4010	2013-08-22
ICL	Carbol Fuchsin	Hematology	Class 1	864.1850	2009-04-14
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2001-11-19
JTS	Stains, Microbiologic	Hematology	Class 1	864.1850	2009-04-14
IDC	Acridine Orange	Hematology	Class 1	864.1850	2007-02-07
LDZ	Fixative, Alcohol Containing	Pathology	Class 1	864.4010	2009-04-14
KFD	Aniline Blue	Hematology	Class 1	864.1850	2009-04-14
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2007-02-07
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2024-06-03
DFQ	Sperm, Antigen, Antiserum, Control	Immunology	Class 1	866.5800	2024-06-03
KKK	Sudan Iv	Hematology	Class 1	864.1850	2007-02-07
JSJ	Culture Media, Selective And Non-Differential	Microbiology	Class 1	866.2360	2007-02-07
KJK	Auramine O	Hematology	Class 1	864.1850	2001-11-19
LKS	Device, Parasite Concentration	Microbiology	Class 1	866.2900	2009-04-14
HYF	Giemsa Stain	Hematology	Class 1	864.1850	2007-02-07
ICL	Carbol Fuchsin	Hematology	Class 1	864.1850	2001-11-19
KJO	Brilliant Green	Hematology	Class 1	864.1850	2007-02-07
JTS	Stains, Microbiologic	Hematology	Class 1	864.1850	2001-11-19
IFP	Formalin, Neutral Buffered	Pathology	Class 1	864.4010	2011-12-09
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2011-12-09
LJG	Quality Control Slides	Microbiology	Class 1	866.2660	2009-04-14
JSY	Kit, Identification, Mycobacteria	Microbiology	Class 1	866.2660	2009-04-14

Official Correspondent

Robert Herrick

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CalibreScientific US, Inc.

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
K761138	Zeus Scientific, Inc.	FA TISSUE FIXATIVE & WASH SET	1978-01-06
K842913	E K Ind., Inc.	WRIGHT STAIN FIXATIVE	1984-09-07
K863524	Bd Becton Dickinson Vacutainer Systems Preanalytic	REGAN-LOWE CHARCOAL AGAR	1986-09-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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 2025606. Last updated year: 2026. Please use registration number 2025606 when referencing this establishment in official correspondence.