Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004737529

FEI Number

3004737529

Entity Name

DSRV, INC.

City/State/Country

Mount Olive, NJ, US

Establishment Address

330 Waterloo Valley Rd Suite 200, Mount Olive, NJ 07828, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DSRV INC (Owner Number: 9002901)

Owner / Operator Contact Address

330 Waterloo Valley Rd., Suite 200, Mount Olive, NJ 07828, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K132076

PMA Number

N/A

All Registered Proprietary Names

ExpertCor Routine LA Confirm STA Cleaner Solution (00973) Frozen Format LA Screen LA Screen TriniLIZE PAI-1 Antigen TriniLIZE PAI-1 Activity GradiPlasma LA High GradiPlasma LA Low Frozen Format LA Confirm

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2024-05-02
GIR	Reagent, Russel Viper Venom	Hematology	Class 1	864.8950	2006-06-02
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2017-10-30
GIR	Reagent, Russel Viper Venom	Hematology	Class 1	864.8950	2014-04-24
GIR	Reagent, Russel Viper Venom	Hematology	Class 1	864.8950	2007-12-06
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2017-10-30
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2017-10-30
GGC	Control, Plasma, Abnormal	Hematology	Class 2	864.5425	2006-06-02
GIR	Reagent, Russel Viper Venom	Hematology	Class 1	864.8950	2014-04-24

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DSRV 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

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2432495	BIOCHEMICAL DIAGNOSTICS, INC.	Edgewood, NY, US
3008156187	TECHNO-PATH MANUFACTURING LTD.	Ballina Tipperary, IE
2250051	ORTHO-CLINICAL DIAGNOSTICS, INC.	RARITAN, NJ, US
3021090658	Ortho-Clinical Diagnostics, Inc.	Carlsbad, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004737529. Last updated year: 2026. Please use registration number 3004737529 when referencing this establishment in official correspondence.