Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2250030

FEI Number

2250030

Entity Name

CENOGENICS CORP.

City/State/Country

MORGANVILLE, NJ, US

Establishment Address

100 RT. 520, Drawer 308, MORGANVILLE, NJ 07751, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

CENOGENICS CORPORATION (Owner Number: 2243923)

Owner / Operator Contact Address

100 RT. 520, Morganville, NJ 07751, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K030533

PMA Number

N/A

All Registered Proprietary Names

ROSE BENGAL ANTIGEN BRUCELLA ABORTUS AND BRUCELLA MELITENSIS ANTIGENS BRUCELLA ABORTUS AND BRU PROTEUS "_" (SOMATIC ANTIGEN) MONODEX VDRL ANTIGEN TEST KIT ACCULYSIN-O FEBRILE POSITIVE CONTROL A ACCUNATE ONE-STEP CASSETTE ACCUNATE-CHOICE CHEMVIEW-10 PROFESSIONAL SINGLE SLIDE TEST DENCOCCULT TRI-SLIDE STOOL BLOOD TEST ANTI-STREPTOLYSIN CONTROL SERUM RF Latex Test Set Rheumatex ACCUNATE HOME PREGNANCY TEST

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GSO	Antigens (Febrile), Agglutination, Brucella Spp.	Microbiology	Class 2	866.3085	1977-11-08
GSZ	Antigens, Febrile (Weil-Felix), All Groups	Microbiology	Class 1	866.3410	1977-11-08
KTN	System, Test, Infectious Mononucleosis	Immunology	Class 2	866.5640	1977-11-08
GMQ	Antigens, Nontreponemal, All	Microbiology	Class 2	866.3820	2007-11-19
IBA	Streptolysin O	Pathology	Class 1	864.4400	1977-11-08
GSN	Antiserum, Positive And Negative Febrile Antigen Control Serum	Microbiology	Class 2	866.3085	1977-11-08
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	1999-02-17
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	1977-11-08
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	1977-11-08
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	1977-11-08
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	Class 1	866.3720	1977-11-08
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2010-03-22
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2006-05-16

Official Correspondent

NITZA KATZ

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CENOGENICS CORPORATION

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
K964536	Teco Diagnostics	ONE-STEP DIPSTICK PREGNANCY TEST	1997-02-11
K904016	Bhc Biotech , Ltd.	MAXI TEST	1990-10-15
K870259	Leeco Diagnostics, Inc.	VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044	1987-03-10
K820822	Hybritech, Inc.	TANDEM HCG KIT	1982-04-29
K162333	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo One Step Fecal Occult Blood (FOB) Test	2017-05-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-05	Abbott Health Products, Inc.	2	AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
Z-0081-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.
Z-0082-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status Connect System The Clinitek Status system is a urine analyzer.
Z-0083-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek Status system is a urine analyzer.
Z-0003-2013	Beckman Coulter Inc.	2	IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2250030. Last updated year: 2026. Please use registration number 2250030 when referencing this establishment in official correspondence.