Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2914537

FEI Number

2914537

Entity Name

ANTIBODIES INCORPORATED

City/State/Country

DAVIS, CA, US

Establishment Address

25242 COUNTY ROAD 95, DAVIS, CA 95616, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Antibodies Incorporated (Owner Number: 2914537)

Owner / Operator Contact Address

25242 County Road 95, PO Box 1560, Davis, CA 95616, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BD Sheath Additive BD Detergent Solution Concentrate AntiNuclear Antibody Test (ANA) FACS LYSING SOLUTION Anti-hTERT Antibody (SCD-A7) CrithiDNA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2017-09-28
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2007-12-04
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	2016-05-12
NJT	Immunohistochemistry Reagents And Kits	Hematology	Class 1	864.1860	2017-01-05
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2014-04-09
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2012-06-27
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2014-02-28
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2014-02-28
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2014-02-28

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Antibodies Incorporated

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3032523590	Antibodies Incorporated	Davis, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880742	Inova Diagnostics, Inc.	NOVA LITE(TM) DSDNA	1988-03-25
K910283	Danam Electronics	DANAM DATACELL-18	1991-04-12
K102064	Becton, Dickinson & CO	BD FACS SAMPLE PREP ASSISTANT III (SPA III)	2011-03-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0003-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0011-2014	Siemens Healthcare Diagnostics	2	ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.
Z-0021-2013	Beckman Coulter Inc.	2	Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: " Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. " Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF).
Z-0033-2013	Beckman Coulter Inc.	2	CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.

Similar Registrations

Registration Number	Establishment Name	Location
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3005181013	TAKARA BIOTECHNOLOGY (DALIAN) CO., LTD.	Dalian Liaoning, CN
3006537286	AUTOBIO DIAGNOSTICS CO., LTD.	Zhengzhou Henan, CN
3036685103	REAGENT	Runcorn Cheshire West and Chester, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2914537. Last updated year: 2026. Please use registration number 2914537 when referencing this establishment in official correspondence.