Princeton BioMeditech Corp.
Monmouth Jct, NJ, US
Princeton BioMeditech Corp. appears in FDA device records in Monmouth Jct, NJ. FDA records list 72 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 72FDA records hold 72 510(k) clearances for Princeton BioMeditech Corp. between 1994 and 2025. The busiest year on record is 1995, with 12. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1995 | 12 |
| 1996 | 10 |
| 1997 | 4 |
| 1998 | 10 |
| 1999 | 12 |
| 2000 | 1 |
| 2002 | 7 |
| 2003 | 1 |
| 2004 | 1 |
| 2006 | 1 |
| 2007 | 2 |
| 2008 | 2 |
| 2010 | 3 |
| 2013 | 2 |
| 2014 | 1 |
| 2018 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251538 | Status™ COVID-19/Flu A&B | SCA | Substantially Equivalent | |
| K182157 | BioSign Flu A+B | PSZ | Substantially Equivalent | |
| K130650 | STATUS DS OXY | DJG | Substantially Equivalent | |
| K133474 | BIOSIGN FLU A + B, STATUS FLU A & B | PSZ | Substantially Equivalent | |
| K132465 | BIOSIGN FLU A + B, STATUS FLU A & B | PSZ | Substantially Equivalent | |
| K083746 | BIOSIGN FLU A+B | PSZ | Substantially Equivalent | |
| K100817 | BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST | KHE | Substantially Equivalent | |
| K100341 | SPERMCHECK FERTILITY | POV | Substantially Equivalent | |
| K082661 | BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A | GTY | Substantially Equivalent | |
| K073039 | SPERMCHECK VASECTOMY | POV | Substantially Equivalent | |
| K062575 | MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP | LAG | Substantially Equivalent | |
| K062565 | STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE | MKU | Substantially Equivalent | |
| K050955 | LIFESIGN DXPRESS, MODEL LSR2000 | JHI | Substantially Equivalent | |
| K040708 | STATUS FIRST STREP A | GTY | Substantially Equivalent | |
| K023837 | LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA | LAF | Substantially Equivalent | |
| K022946 | LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST | MMI | Substantially Equivalent | |
| K014069 | LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC | DIO | Substantially Equivalent | |
| K014067 | LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC | DIO | Substantially Equivalent | |
| K014066 | LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC | LDJ | Substantially Equivalent | |
| K020439 | STATUS HCG SERUM/URINE | JHI | Substantially Equivalent | |
| K014193 | LIFESIGN DOA 4 (THC/OPI/COC/MET) | LDJ | Substantially Equivalent | |
| K014192 | LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET | MVO | Substantially Equivalent | |
| K001225 | ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U. | DKZ | Substantially Equivalent | |
| K992422 | ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000 | DJG | Substantially Equivalent | |
| K992068 | STATUS STIK, ACCUSIGN STIK | DKE | Substantially Equivalent | |
| K991751 | STATUS CUP ACCUSIGN CUP | DKE | Substantially Equivalent | |
| K991299 | MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI | JHT | Substantially Equivalent | |
| K991084 | ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD | DIS | Substantially Equivalent | |
| K991082 | ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO | DIS | Substantially Equivalent | |
| K991080 | ACCUSIGN MTD, BIOSIGN MTD | DJR | Substantially Equivalent | |
| K991079 | ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO | JXM | Substantially Equivalent | |
| K991078 | ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8 | DKE | Substantially Equivalent | |
| K991076 | ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP | DIS | Substantially Equivalent | |
| K991018 | ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR | DIS | Substantially Equivalent | |
| K990786 | ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/ | LAG | Substantially Equivalent | |
| K983501 | ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/ | LAG | Substantially Equivalent | |
| K983386 | BIOSTREP A-DIRECT STREP A ANTIGEN TEST | GTY | Substantially Equivalent | |
| K983147 | ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P | DKE | Substantially Equivalent | |
| K980798 | BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST | LYR | Substantially Equivalent | |
| K981801 | ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA | LFH | Substantially Equivalent | |
| K981444 | BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP | JHI | Substantially Equivalent | |
| K981882 | CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST | MMI | Substantially Equivalent | |
| K981443 | BIOSIGN HCG I - ONE STEP PREGNANCY TEST | JHI | Substantially Equivalent | |
| K981771 | ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP | DJG | Substantially Equivalent | |
| K980249 | ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA | LFG | Substantially Equivalent | |
| K974425 | BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST | DHA | Substantially Equivalent | |
| K974181 | ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B | JXM | Substantially Equivalent | |
| K971349 | BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST | GTY | Substantially Equivalent | |
| K961024 | BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB | KTN | Substantially Equivalent | |
| K963693 | OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST | CEP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2246703 | 2246703 | PRINCETON BIOMEDITECH CORP. | 4242 U.S. Hwy. 1, Monmouth Jct, NJ 08852 US | 2026 | and 33 more, listed in full below |
| 3026478115 | 3026478115 | Princeton BioMeditech Corp. | 85 Orchard Rd, Skillman, NJ 08558 US | 2026 | and 30 more, listed in full below |
| 3026478116 | 3026478116 | Princeton BioMeditech Corp. | 311 Enterprise Dr, Plainsboro, NJ 08536 US | 2026 | and 30 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GTYAntigens, All Groups, Streptococcus Spp.
- GTNAntisera, Fluorescent, All Types, Staphylococcus Spp.
- JHTChromatographic Separation, Cpk Isoenzymes
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- QKPCoronavirus Antigen Detection Test System.
- PSZDevices Detecting Influenza A, B, And C Virus Antigens
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- MKUEnzyme Immunoassay, Nicotine And Nicotine Metabolites
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella
- DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- LAFGas Chromatography, Methamphetamine
- LYRHelicobacter Pylori
- LAGHigh Pressure Liquid Chromatography, Methamphetamine
- LFIHigh Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs
- MMIImmunoassay Method, Troponin Subunit
- MVOKit, Test, Multiple, Drugs Of Abuse, Over The Counter
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- LOJKit, Test,Alpha-Fetoprotein For Testicular Cancer
- DNILiquid Chromatography, Amphetamine
- SCAMulti-Analyte Respiratory Virus Antigen Detection Test
- DDRMyoglobin, Antigen, Antiserum, Control
- DEAMyoglobin, Fitc, Antigen, Antiserum, Control
- DKNRadioimmunoassay, Barbiturate
- CEPRadioimmunoassay, Luteinizing Hormone
- LFGRadioimmunoassay, Tricyclic Antidepressant Drugs
- KHEReagent, Occult Blood
- DKEReagents, Test, Tetrahydrocannabinol
- POVSemen Analysis Device
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- DHASystem, Test, Human Chorionic Gonadotropin
- KTNSystem, Test, Infectious Mononucleosis
- MGXTest System, For Drugs Of Abuse
- NBCTest, Natriuretic Peptide
- DJCThin Layer Chromatography, Methamphetamine
- JHWU.V. Method, Cpk Isoenzymes
- LFHU.V. Spectrometry, Tricyclic Antidepressant Drugs
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0259-2025 | Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. Model/Catalog Number: 1004 | This recall was initiated due to customer complaints of false negative of hCG test results when running patient urine samples. Use of the above listed product lot may result in false negative results. An end user reported that the OSOM Ultra hCG Combo Test, lot 563L13, produced false negative test results from 2 patient urine samples as confirmed by quantitative hCG and ultrasound. During further root cause testing and investigation, an additional 6 devices were found to produce false negative test results from hCG positive samples. | Class II | Open, Classified | |
| Z-2308-2012 | Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Junction, NJ 08852 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use. | There have been reports of dual positive (Flu A + Flu B positive) results being encountered. | Class II | Terminated | |
| Z-2307-2012 | Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY 10567 Tel 800-431-2123 914-739-5400 Fax 914-739-5890. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use. | There have been reports of dual positive (Flu A + Flu B positive) results being encountered. | Class II | Terminated | |
| Z-2306-2012 | Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use. | There have been reports of dual positive (Flu A + Flu B positive) results being encountered. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Princeton BioMeditech Corp. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain