Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003691680

FEI Number

3003691680

Entity Name

BIOMEDICA DIAGNOSTICS INC.

City/State/Country

Windsor Nova Scotia, CA

Establishment Address

94 Wentworth Road, Windsor Nova Scotia B0N 2T0, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BioMedica Diagnostics Inc. (Owner Number: 9050020)

Owner / Operator Contact Address

94 Wentworth Road, Windsor, CA-NS B0N 2T0, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K940490

PMA Number

N/A

All Registered Proprietary Names

ACTICLOT dPT IMUBIND vWF Activity ELISA QuickCoag APTT-EA ACTICLOT Protein S IMUBIND Plasma PAI-1 ELISA DIMERTEST Latex ACTICHROME Heparin (Anti-FXa) ACTICLOT Activated Protein C Resistance Control Plasma QuickCoag Low Abnormal Control Level 2 QuickCoag High Abnormal Control Level 3 QuickCoag Normal Control Level 1 ACTICHROME AT III QuickCoag PT-HS DVV confirm 10 DVVtest 10 DVV confirm 5

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2016-12-19
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2016-12-19
GFO	Activated Partial Thromboplastin	Hematology	Class 2	864.7925	2002-04-03
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2016-12-20
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2016-12-20
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2016-12-20
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2016-12-20
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2016-12-19
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2002-04-08
JBQ	Antithrombin Iii Quantitation	Hematology	Class 2	864.7060	2016-12-19
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2002-04-08
GIR	Reagent, Russel Viper Venom	Hematology	Class 1	864.8950	2016-12-19

Official Correspondent

Daniel Moreno

US Agent Details

David Teicher Business: BIOMEDICA DIAGNOSTICS INC Email: dteicher@biomedicadiagnostics.com Phone: (914) 4844146

Related Public Records

Same Entity

BioMedica Diagnostics 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
K020679	Hemosense, Inc.	INRATIO	2002-05-06
K070005	Instrumentation Laboratory CO	HEMOSIL RECOMBIPLASTIN 2G	2007-08-15
K931117	Instrumentation Laboratory CO	ASSESS(TM) LOW ABNORMAL CONTROL	1994-03-30
K933252	Instrumentation Laboratory CO	IL TEST (TM) PT-FIBRINOGEN HS PLUS	1993-10-04
K972288	Universal Reagents, Inc.	FACTOR DEFICIENT PLASMAS - FACTOR IX (9)	1997-07-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0077-2019	Instrumentation Laboratory Co.	2	Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.
Z-0832-2015	Instrumentation Laboratory Co.	2	HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
Z-0895-2018	Instrumentation Laboratory Co.	2	Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
Z-1246-06	Instrumentation Laboratory Co.	2	HemosIL RecombiPlasTin. Prothrombin Time Test. Each RecombiPlasTin kit consists of: RecombiPlasTin (RTF): 5 x 8 mL or 20 mL vials of lyophilized recombinant human tissue factor, synthetic phospholipids with stabilizers, preservative and buffer; and RecombiPlasTin Diluent (RTF Diluent): 5 x 8 or 20 mL vials of an aqueous solution of calcium chloride, polybrene and a preservative. --- FOR IN VITRO DIAGNOSTIC USE.
Z-1247-06	Instrumentation Laboratory Co.	2	Hemoliance RecombiPlasTin. Prothrombin Time Test. The product is available as a kit of 25 vials of Hemoliance RecombiPlasTin matched with 25 vials of Hemoliance RecombiPlasTin Diluent. Hemoliance RecombiPlasTin after reconstitution with Hemoliance RecombiPlasTin Diluent is a liposomal preparation of recombinant human tissue factor and purified phospholipids, calcium chloride, buffer and a preservative. The use of recombinant human tissue factor and purified phospholipids assures uniformity in reagent purity, ISI values and performance from lot to lot. Once reconstituted, it is ready for use in the one-stage PT test. Hemoliance RecombiPlasTin Diluent is an aqueous solution of calcium chloride and a preservative. --- FOR IN VITRO DIAGNOSTIC USE.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003691680. Last updated year: 2026. Please use registration number 3003691680 when referencing this establishment in official correspondence.