FDA.reportPublic FDA data

Princeton BioMeditech Corp.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
Princeton BioMeditech Corp.5N2026-01-01311 Enterprise Dr Plainsboro NJ US 08536
Princeton BioMeditech Corp.5N2026-01-0185 Orchard Rd Skillman NJ US 08558
22467032246703PRINCETON BIOMEDITECH CORP.1N2026-01-014242 U.S. Hwy. 1 Monmouth Jct NJ US 08852

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10743816000730Status™ hCG strip - Status™ hCG strip; 35 Test kit8005262125info@lifesignmed.com
10743816000747BioStrip® P - BioStrip® P; 25 Test kit; CE7322741000info@pbmc.com
10743816000754BioStrip® P - BioStrip® P; 50 Test kit; CE7322741000info@pbmc.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
67031766431755K992068STATUS STIK, ACCUSIGN STIKDKE1999-07-06
3520481766431755K992068STATUS STIK, ACCUSIGN STIKDKE1999-07-06
3520541766431755K992068STATUS STIK, ACCUSIGN STIKDKE1999-07-06
67031338457846K991299MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBIJHT1999-05-28
3520481338457846K991299MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBIJHT1999-05-28
3520541338457846K991299MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBIJHT1999-05-28
67031212545050K991082ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZODIS1999-04-15
3520481212545050K991082ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZODIS1999-04-15
3520541212545050K991082ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZODIS1999-04-15
67031746782241K991080ACCUSIGN MTD, BIOSIGN MTDDJR1999-04-15
3520481746782241K991080ACCUSIGN MTD, BIOSIGN MTDDJR1999-04-15
3520541746782241K991080ACCUSIGN MTD, BIOSIGN MTDDJR1999-04-15
67031835183156K991079ACCUSIGN BZO, BIOSIGN BZO, STATUS BZOJXM1999-04-15
3520481835183156K991079ACCUSIGN BZO, BIOSIGN BZO, STATUS BZOJXM1999-04-15
3520541835183156K991079ACCUSIGN BZO, BIOSIGN BZO, STATUS BZOJXM1999-04-15
67031991846173K991078ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8DKE1999-04-15
3520481991846173K991078ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8DKE1999-04-15
3520541991846173K991078ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8DKE1999-04-15
67031632591513K991018ACCUSIGN BAR, BIOSIGN BAR, STATUS BARDIS1999-04-15
3520481632591513K991018ACCUSIGN BAR, BIOSIGN BAR, STATUS BARDIS1999-04-15
3520541632591513K991018ACCUSIGN BAR, BIOSIGN BAR, STATUS BARDIS1999-04-15
67031557243522K990786ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/LAG1999-03-26
3520481557243522K990786ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/LAG1999-03-26
3520541557243522K990786ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/LAG1999-03-26
67031255552493K983501ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/LAG1998-12-18
3520481255552493K983501ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/LAG1998-12-18
3520541255552493K983501ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/LAG1998-12-18
67031047461342K983386BIOSTREP A-DIRECT STREP A ANTIGEN TESTGTY1998-11-25
3520481047461342K983386BIOSTREP A-DIRECT STREP A ANTIGEN TESTGTY1998-11-25
3520541047461342K983386BIOSTREP A-DIRECT STREP A ANTIGEN TESTGTY1998-11-25
67031164590553K983147ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/PDKE1998-09-28
3520481164590553K983147ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/PDKE1998-09-28
3520541164590553K983147ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/PDKE1998-09-28
67031734784760K981882CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TESTMMI1998-07-06
3520481734784760K981882CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TESTMMI1998-07-06
3520541734784760K981882CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TESTMMI1998-07-06
67031795500897K981801ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCALFH1998-08-25
3520481795500897K981801ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCALFH1998-08-25
3520541795500897K981801ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCALFH1998-08-25
67031221102289K981771ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOPDJG1998-06-12
3520481221102289K981771ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOPDJG1998-06-12
3520541221102289K981771ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOPDJG1998-06-12
67031083142135K980798BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TESTLYR1998-09-22
3520481083142135K980798BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TESTLYR1998-09-22
3520541083142135K980798BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TESTLYR1998-09-22
67031533641145K980249ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCALFG1998-03-13
3520481533641145K980249ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCALFG1998-03-13
3520541533641145K980249ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCALFG1998-03-13
67031088346479K974425BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TESTDHA1997-12-24
3520481088346479K974425BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TESTDHA1997-12-24
3520541088346479K974425BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TESTDHA1997-12-24
67031151257832K971349BIOSIGN STREP A - DIRECT STREP A ANTIGEN TESTGTY1997-07-07
3520481151257832K971349BIOSIGN STREP A - DIRECT STREP A ANTIGEN TESTGTY1997-07-07
3520541151257832K971349BIOSIGN STREP A - DIRECT STREP A ANTIGEN TESTGTY1997-07-07
67031630117680K963693OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TESTCEP1996-11-29
3520481630117680K963693OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TESTCEP1996-11-29
3520541630117680K963693OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TESTCEP1996-11-29
67031528528229K963513CARDIAC STATUS TROPONIN IMMI1996-11-07
3520481528528229K963513CARDIAC STATUS TROPONIN IMMI1996-11-07
3520541528528229K963513CARDIAC STATUS TROPONIN IMMI1996-11-07
67031987327182K962673ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAYDJR1996-08-15
3520481987327182K962673ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAYDJR1996-08-15
3520541987327182K962673ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAYDJR1996-08-15
67031470508478K962672ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAYJXM1996-08-30
3520481470508478K962672ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAYJXM1996-08-30
3520541470508478K962672ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAYJXM1996-08-30
67031076378124K962669ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAYDIS1996-08-15
3520481076378124K962669ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAYDIS1996-08-15
3520541076378124K962669ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAYDIS1996-08-15
67031010963956K962353ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP)DIO1996-08-19
3520481010963956K962353ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP)DIO1996-08-19
3520541010963956K962353ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP)DIO1996-08-19
67031513782334K961266ACCUSIGN, BIOSIGN PCPLCM1996-05-31
3520481513782334K961266ACCUSIGN, BIOSIGN PCPLCM1996-05-31
3520541513782334K961266ACCUSIGN, BIOSIGN PCPLCM1996-05-31
67031157296725K961249ACCUSIGN MET/BIOSIGN METLAF1996-04-25
3520481157296725K961249ACCUSIGN MET/BIOSIGN METLAF1996-04-25
3520541157296725K961249ACCUSIGN MET/BIOSIGN METLAF1996-04-25
67031011636942K961024BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WBKTN1997-02-04
3520481011636942K961024BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WBKTN1997-02-04
3520541011636942K961024BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WBKTN1997-02-04
67031618300322K954571ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPIDIO1995-11-03
3520481618300322K954571ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPIDIO1995-11-03
3520541618300322K954571ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPIDIO1995-11-03
67032058383507K952361ABUSIGN DOA 2, DOA, COC/THC, DOA2, BIOSIGN DOA2, COC/THCDIO1995-10-26
3520482058383507K952361ABUSIGN DOA 2, DOA, COC/THC, DOA2, BIOSIGN DOA2, COC/THCDIO1995-10-26
3520542058383507K952361ABUSIGN DOA 2, DOA, COC/THC, DOA2, BIOSIGN DOA2, COC/THCDIO1995-10-26
67031170909680K952360CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBINDDR1995-08-14
3520481170909680K952360CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBINDDR1995-08-14
3520541170909680K952360CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBINDDR1995-08-14
67032051161943K950307BIOSTRIP(R) HCG-ONE STEP PREGNANCY TESTDHA1995-03-01
3520482051161943K950307BIOSTRIP(R) HCG-ONE STEP PREGNANCY TESTDHA1995-03-01
3520542051161943K950307BIOSTRIP(R) HCG-ONE STEP PREGNANCY TESTDHA1995-03-01
67031261091931K945610ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMPDKZ1995-04-13
3520481261091931K945610ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMPDKZ1995-04-13
3520541261091931K945610ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMPDKZ1995-04-13
67031946016662K945609ABUSIGN(TM) COC, DOA-COC, ACCUSIGN(TM) COC, DOA-COC, DIOSIGN(TM) COC, DOA-COCDIO1995-02-22
3520481946016662K945609ABUSIGN(TM) COC, DOA-COC, ACCUSIGN(TM) COC, DOA-COC, DIOSIGN(TM) COC, DOA-COCDIO1995-02-22
3520541946016662K945609ABUSIGN(TM) COC, DOA-COC, ACCUSIGN(TM) COC, DOA-COC, DIOSIGN(TM) COC, DOA-COCDIO1995-02-22
67031620908116K945608ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPIDJG1995-02-10
3520481620908116K945608ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPIDJG1995-02-10
3520541620908116K945608ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPIDJG1995-02-10
67031089174859K945550ABUSIGN(TM) THC, DOA-THC, ACCUSIGN(TM) THC, DOA-THC, DIOSIGN(TM) THC, DOA-THCLDJ1995-02-22
3520481089174859K945550ABUSIGN(TM) THC, DOA-THC, ACCUSIGN(TM) THC, DOA-THC, DIOSIGN(TM) THC, DOA-THCLDJ1995-02-22
3520541089174859K945550ABUSIGN(TM) THC, DOA-THC, ACCUSIGN(TM) THC, DOA-THC, DIOSIGN(TM) THC, DOA-THCLDJ1995-02-22
67031113499857K945549ABUSIGN(TM) DOA 4, DOA, THC/OPI/COC/AMP OR MET, BIOSIGN(TM) DOA 4, THC/OPI/COC/AMP OR METDIO1995-10-26
3520481113499857K945549ABUSIGN(TM) DOA 4, DOA, THC/OPI/COC/AMP OR MET, BIOSIGN(TM) DOA 4, THC/OPI/COC/AMP OR METDIO1995-10-26
3520541113499857K945549ABUSIGN(TM) DOA 4, DOA, THC/OPI/COC/AMP OR MET, BIOSIGN(TM) DOA 4, THC/OPI/COC/AMP OR METDIO1995-10-26
67031893682870K945514LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCGLCX1995-02-10
3520481893682870K945514LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCGLCX1995-02-10
3520541893682870K945514LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCGLCX1995-02-10
67031122507152K944426BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINEJHI1994-10-25
3520481122507152K944426BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINEJHI1994-10-25
3520541122507152K944426BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINEJHI1994-10-25
67031482053906K943439ABUSIGN DOA4DKZ1995-02-22
3520481482053906K943439ABUSIGN DOA4DKZ1995-02-22
3520541482053906K943439ABUSIGN DOA4DKZ1995-02-22
67031082232301K930185OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEPCEP1993-03-04
3520481082232301K930185OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEPCEP1993-03-04
3520541082232301K930185OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEPCEP1993-03-04

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DIO212002-06-10
GTY122008-10-06
DJG92014-02-26
PSZ92013-12-10
LAG92007-11-26
JHI92006-01-23
MMI92002-10-08
LDJ92002-06-10
DKE91999-07-06
DIS91999-04-15
POV62010-05-04
JXM61999-04-15
DJR61999-04-15
DHA61997-12-24
CEP61996-11-29
DKZ61995-04-13
LCX61995-02-10
SCA32025-11-14
KHE32010-07-01
MKU32007-02-20
MVO32002-05-23
JHT31999-05-28
LYR31998-09-22
LFH31998-08-25
LFG31998-03-13
KTN31997-02-04
LCM31996-05-31
LAF31996-04-25
DDR31995-08-14
LFX31994-07-12

PMN#

72 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next