Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1835316

FEI Number

3000210416

Entity Name

R2 DIAGNOSTICS, INC.

City/State/Country

SOUTH BEND, IN, US

Establishment Address

1801 COMMERCE DR., SOUTH BEND, IN 46628, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

R2 DIAGNOSTICS, INC. (Owner Number: 9026432)

Owner / Operator Contact Address

1801 COMMERCE DR., --, South Bend, IN 46628, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K102908

PMA Number

N/A

All Registered Proprietary Names

ThromboTek PSe Lupotek KCT LupoTek CorrecTin VL, DetecTin VL, PlasmaConLA FIBRO TEK FIB NOFACT VIII PHOSPHOLLIN-ES AND CALCIUM CHLORIDE PLASMACON NOFACT IX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2009-03-19
GGW	Test, Time, Partial Thromboplastin	Hematology	Class 2	864.7925	2015-10-21
GIR	Reagent, Russel Viper Venom	Hematology	Class 1	864.8950	2010-12-22
GGC	Control, Plasma, Abnormal	Hematology	Class 2	864.5425	2010-12-22
GIS	Test, Fibrinogen	Hematology	Class 2	864.7340	2006-09-25
KQJ	System, Fibrinogen Determination	Hematology	Class 2	864.7340	2006-09-25
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2013-01-07
GGW	Test, Time, Partial Thromboplastin	Hematology	Class 2	864.7925	2003-11-12
GGC	Control, Plasma, Abnormal	Hematology	Class 2	864.5425	2007-12-18
GIZ	Plasma, Control, Normal	Hematology	Class 2	864.5425	2007-12-18
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2013-01-07

Official Correspondent

MICHAEL MORRIS

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

R2 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
K972288	Universal Reagents, Inc.	FACTOR DEFICIENT PLASMAS - FACTOR IX (9)	1997-07-14
K010379	Instrumentation Laboratory CO	IL TEST FREE PROTEIN S	2001-04-13
K033631	Instrumentation Laboratory CO	MODIFICATION TO COATEST FACTOR VIII	2003-12-15
K924884	Instrumentation Laboratory CO	IL TEST(TM) PRO-CHROM	1993-01-14
K042576	Instrumentation Laboratory CO	COATEST SP FVIII	2004-12-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0736-2016	Instrumentation Laboratory Co.	2	HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate
Z-1519-2012	Instrumentation Laboratory Co.	2	Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit Part Number: 0020004700 The assay is intended for the quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems

Similar Registrations

Registration Number	Establishment Name	Location
2431530	INSTRUMENTATION LABORATORY CO.	ORANGEBURG, NY, US
3037000637	INSTRUMENTATION LABORATORY CO. - Devens	Devens, MA, US
9710666	Diagnostica Stago - Taverny	Taverny Val-d'Oise, FR
1217183	INSTRUMENTATION LABORATORY CO.	Bedford, MA, US
2245451	DIAGNOSTICA STAGO, INC.	PARSIPPANY, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1835316. Last updated year: 2026. Please use registration number 1835316 when referencing this establishment in official correspondence.