Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2246703

FEI Number

2246703

Entity Name

PRINCETON BIOMEDITECH CORP.

City/State/Country

Monmouth Jct, NJ, US

Establishment Address

4242 U.S. Hwy. 1, Monmouth Jct, NJ 08852, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PRINCETON BIOMEDITECH CORP. (Owner Number: 2246703)

Owner / Operator Contact Address

4242 U.S. HIGHWAY 1, --, Monmouth Junction, NJ 08852, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K952361

PMA Number

N/A

All Registered Proprietary Names

SpermCheck Fertility BioSign Mono Status Mono Status DS Oxy Accusign MET BioStrip P Status hCG Strip BIOSIGN STREP A--DIRECT STR Accusign TCA DBdau DOA7 (THC/OPI/COC/MET//BAR/BZO/AMP) Accusign BUP BioSign Rubella BioStrepA Status First Strep A BioSign Strep A AccuSign RC DOA 10 (MET/OPI/COC/THC Status First DOA 10 StatusFirst DOA10/StatusFirst DOA5 Status Strep A Strip StatusStrep A Plus Accusign MTD STATUS HCG BIOSIGN HCG Status Nicotine AccuSign Nicotine Status hCG S/U BioSign hCG S/U BioSign Flu A+B StatusFlu A&B LifeSign Home Drug Test (THC/COC) Accusign BAR Status DS DOA 9 AccuSign DOA 10 Status DS DOA 10 AccuSign DOA 8 AccuSign DOA 9 Status Stik THC/OPI/COC/AMP or MET/ Status iFOBT BioSign iFOBTest Accusign BZO ACCUSIGN DOA 10 Panel STATUS STIK COC LIFESIGN HOME DRUG TEST COC Status DS (COC/THC/OPI) AccuSign DOA3 (COC/THC/OPI) Status First Sperm Check Vasectomy AccuSign BAR Status DS BAR Status DS THC/OPI/COC/AMP/BZO/BAR/T AccuSign DOA8 (THC/OPI/COC/AMP/BZO/ Status DS MET AccuSign MET Status COVID-19/Flu control set (5 Pos/5 Neg) BioSign Mono Pos/Neg control Status Mono Pos/Neg controls (2 x 1 mL) BioSign Flu control set (5 Pos/5 Neg) Status Flu control set (5 Pos/5 Neg) Status iFOBT control set Pos/Neg (2 x 1 mL) PBM Qualitative Cardiac Marker Control Set (2 x 1mL) Status Drugs of Abuse Controls (2 x 5mL) Status hCG urine Pos/Neg controls (2 x 2.5 mL) BioSign hCG S/U Pos/Neg controls (2 x 3 mL) Status COVID-19 Antigen Controls (1 pos/1 neg); Bulk Status H. pylori Pos/Neg controls (2 x 1 mL) Cardiac Status Troponin I LifeSign MI Troponin I Status DS BZO AccuSign BZO BioSign hCG S/U BioSign Strep A Status AccuStrep A Status DS AMP or MET AccuSign DOA 4/AMP or MET ACCUSIGN OPI StatusFirst D-Dimer Status DS (THC/OPI/COC/MET or AMP/P AccuSign DOA5 (THC/OPI/COC/MET or A Status Strep A Flip BioSign Strep A Flip Status First Strep A BioSign Flu A+B Status Flu A&B Status DS TCA AccuSign TCA LifeSign Plus StatusFirst TnI Quantitative LifeSign One LifeSign 1 Status COVID-19/Flu A&B STATUS CK-MB/MYO StatusFirst hCG Serum/Urine LIFESIGN DX READER LifeSign MI CK-MB/Myoglobin/Trop I Cardiac STATus CK-MB/Myoglob/Trop I Clarity Status DS AMP AccuSign AMP Status DS THC AccuSign THC AccuSign COC StatusDS COC AccuSign PCP Status DS PCP AccuSign DOA 2 COC/THC Status DS COC/THC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
POV	Semen Analysis Device	Hematology	Class 2	864.5220	2010-12-13
KTN	System, Test, Infectious Mononucleosis	Immunology	Class 2	866.5640	1992-10-08
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2014-11-18
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2015-11-18
MVO	Kit, Test, Multiple, Drugs Of Abuse, Over The Counter	Unknown	Class U	N/A	2015-11-18
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2007-12-11
GTN	Antisera, Fluorescent, All Types, Staphylococcus Spp.	Microbiology	Class 1	866.3700	1998-04-06
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2015-11-18
MGX	Test System, For Drugs Of Abuse	Unknown	Class 3	N/A	2014-01-22
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2013-12-17
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	Microbiology	Class 2	866.3510	2007-12-12
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2008-12-11
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2007-12-12
DKE	Reagents, Test, Tetrahydrocannabinol	Clinical Toxicology	Class 2	862.3870	2007-12-12
LFI	High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2007-12-12
LAG	High Pressure Liquid Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2007-12-12
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2007-12-12
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2007-12-12
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2007-12-12
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2007-12-12
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2007-12-12
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2007-12-12
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2007-12-12
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2015-11-18
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	1992-10-08
MKU	Enzyme Immunoassay, Nicotine And Nicotine Metabolites	Clinical Toxicology	Class 1	862.3220	2007-12-12
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	1994-09-09
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2010-12-13
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2007-12-12
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2015-11-18
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2007-12-12
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2007-12-12
DKE	Reagents, Test, Tetrahydrocannabinol	Clinical Toxicology	Class 2	862.3870	2007-12-12
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2007-12-12
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2007-12-12
DKN	Radioimmunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2007-12-12
LFI	High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2007-12-12
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2007-12-12
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2007-12-12
LAG	High Pressure Liquid Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2007-12-12
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2007-12-12
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2007-12-12
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2007-12-12
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2007-12-12
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2007-12-12
DKE	Reagents, Test, Tetrahydrocannabinol	Clinical Toxicology	Class 2	862.3870	2007-12-12
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2010-12-13
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2015-11-18
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2015-11-18
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2015-11-18
LAG	High Pressure Liquid Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2015-11-18
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2015-11-18
DKN	Radioimmunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2015-11-18
DKE	Reagents, Test, Tetrahydrocannabinol	Clinical Toxicology	Class 2	862.3870	2015-11-18
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2015-11-18
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2015-11-18
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2015-11-18
LFI	High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2015-11-18
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	1998-04-06
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2007-12-12
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2007-12-12
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2007-12-12
POV	Semen Analysis Device	Hematology	Class 2	864.5220	2008-03-06
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2007-12-12
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2007-12-12
LFI	High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2007-12-12
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2007-12-12
DKN	Radioimmunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2007-12-12
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2007-12-12
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2007-12-12
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2007-12-12
DKE	Reagents, Test, Tetrahydrocannabinol	Clinical Toxicology	Class 2	862.3870	2007-12-12
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2007-12-12
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2019-03-29
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2007-12-12
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2007-12-12
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2005-09-07
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2007-12-12
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2007-12-12
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2007-12-12
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2007-12-12
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2007-12-12
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	1995-12-11
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2013-12-17
DNI	Liquid Chromatography, Amphetamine	Clinical Toxicology	Class 2	862.3100	2007-12-12
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2007-12-12
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2007-12-12
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2006-04-19
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2014-11-18
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2007-12-12
LFH	U.V. Spectrometry, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2007-12-12
LFI	High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2007-12-12
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2007-12-11
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2013-12-17
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2007-12-11
SCA	Multi-Analyte Respiratory Virus Antigen Detection Test	Microbiology	Class 2	866.3987	2025-12-08
DDR	Myoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2015-11-18
JHT	Chromatographic Separation, Cpk Isoenzymes	Clinical Chemistry	Class 2	862.1215	2015-11-18
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2006-03-06
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2006-03-06
DEA	Myoglobin, Fitc, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2007-12-12
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2007-12-12
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2007-12-12
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2007-12-12
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2007-12-10
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2007-12-12
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2007-12-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PRINCETON BIOMEDITECH CORP.

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
K153050	Co-Innovation Biotech Co., Ltd.	Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard	2016-04-26
K151478	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo CR3 Keyless Split Sample Cup	2015-07-01
K150179	Guangzhou Wondfo Biotech Co., Ltd.	CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids	2015-02-25
K112310	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO METHADONE URINE TEST,OPIATE TEST	2011-09-08
K093175	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES	2010-08-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-06	Nichols Institute Diagnostics	2	Nichols Advantage Invasive Trophoblast Antigen (ITA)Assay Cartridges (Catalog #62-7052)
Z-0007-06	Nichols Institute Diagnostics	2	Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039)
Z-0081-2017	Siemens Healthcare Diagnostics, Inc.	2	SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age.
Z-0082-2017	Siemens Healthcare Diagnostics, Inc.	2	SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/Catalog # for OUS: L2KRM2, SMN for OUS: 10381327; Unique Device Identification Number (UDI) 00630414961996; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age
Z-0006-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

Similar Registrations

Registration Number	Establishment Name	Location
3014295858	COOPER MEDICAL, SRL	La Garita Alajuela, CR
3016090200	BONRAYBIO USA CORPORATION	Diamond Bar, CA, US
1221433	HAMILTON THORNE, Inc.	Beverly, MA, US
3003646592	MEDICAL ELECTRONIC SYSTEMS LTD.	CAESAREA IND. PARK Haifa, IL
3015550658	MOTILITYCOUNT APS	Valby Hovedstaden, DK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2246703. Last updated year: 2026. Please use registration number 2246703 when referencing this establishment in official correspondence.