Status? COVID-19/Flu A&B
Princeton BioMeditech Corp.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2246703 | 2246703 | PRINCETON BIOMEDITECH CORP. | 1 | N | 2026-01-01 | 4242 U.S. Hwy. 1 Monmouth Jct NJ US 08852 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 10743816000730 | Status™ hCG strip - Status™ hCG strip; 35 Test kit | 8005262125 | info@lifesignmed.com |
| 10743816000747 | BioStrip® P - BioStrip® P; 25 Test kit; CE | 7322741000 | info@pbmc.com |
| 10743816000754 | BioStrip® P - BioStrip® P; 50 Test kit; CE | 7322741000 | info@pbmc.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 6703 | 1766431755 | K992068 | STATUS STIK, ACCUSIGN STIK | DKE | 1999-07-06 |
| 6703 | 1338457846 | K991299 | MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI | JHT | 1999-05-28 |
| 6703 | 1212545050 | K991082 | ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO | DIS | 1999-04-15 |
| 6703 | 1746782241 | K991080 | ACCUSIGN MTD, BIOSIGN MTD | DJR | 1999-04-15 |
| 6703 | 1835183156 | K991079 | ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO | JXM | 1999-04-15 |
| 6703 | 1991846173 | 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 | 1999-04-15 |
| 6703 | 1632591513 | K991018 | ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR | DIS | 1999-04-15 |
| 6703 | 1557243522 | 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 | 1999-03-26 |
| 6703 | 1255552493 | 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 | 1998-12-18 |
| 6703 | 1047461342 | K983386 | BIOSTREP A-DIRECT STREP A ANTIGEN TEST | GTY | 1998-11-25 |
| 6703 | 1164590553 | 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 | 1998-09-28 |
| 6703 | 1734784760 | K981882 | CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST | MMI | 1998-07-06 |
| 6703 | 1795500897 | K981801 | ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA | LFH | 1998-08-25 |
| 6703 | 1221102289 | K981771 | ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP | DJG | 1998-06-12 |
| 6703 | 1083142135 | K980798 | BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST | LYR | 1998-09-22 |
| 6703 | 1533641145 | K980249 | ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA | LFG | 1998-03-13 |
| 6703 | 1088346479 | K974425 | BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST | DHA | 1997-12-24 |
| 6703 | 1151257832 | K971349 | BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST | GTY | 1997-07-07 |
| 6703 | 1630117680 | K963693 | OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST | CEP | 1996-11-29 |
| 6703 | 1528528229 | K963513 | CARDIAC STATUS TROPONIN I | MMI | 1996-11-07 |
| 6703 | 1987327182 | K962673 | ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY | DJR | 1996-08-15 |
| 6703 | 1470508478 | K962672 | ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY | JXM | 1996-08-30 |
| 6703 | 1076378124 | K962669 | ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY | DIS | 1996-08-15 |
| 6703 | 1010963956 | K962353 | ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP) | DIO | 1996-08-19 |
| 6703 | 1513782334 | K961266 | ACCUSIGN, BIOSIGN PCP | LCM | 1996-05-31 |
| 6703 | 1157296725 | K961249 | ACCUSIGN MET/BIOSIGN MET | LAF | 1996-04-25 |
| 6703 | 1011636942 | K961024 | BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB | KTN | 1997-02-04 |
| 6703 | 1618300322 | K954571 | ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPI | DIO | 1995-11-03 |
| 6703 | 2058383507 | K952361 | ABUSIGN DOA 2, DOA, COC/THC, DOA2, BIOSIGN DOA2, COC/THC | DIO | 1995-10-26 |
| 6703 | 1170909680 | K952360 | CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN | DDR | 1995-08-14 |
| 6703 | 2051161943 | K950307 | BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST | DHA | 1995-03-01 |
| 6703 | 1261091931 | K945610 | ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP | DKZ | 1995-04-13 |
| 6703 | 1946016662 | K945609 | ABUSIGN(TM) COC, DOA-COC, ACCUSIGN(TM) COC, DOA-COC, DIOSIGN(TM) COC, DOA-COC | DIO | 1995-02-22 |
| 6703 | 1620908116 | K945608 | ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPI | DJG | 1995-02-10 |
| 6703 | 1089174859 | K945550 | ABUSIGN(TM) THC, DOA-THC, ACCUSIGN(TM) THC, DOA-THC, DIOSIGN(TM) THC, DOA-THC | LDJ | 1995-02-22 |
| 6703 | 1113499857 | K945549 | ABUSIGN(TM) DOA 4, DOA, THC/OPI/COC/AMP OR MET, BIOSIGN(TM) DOA 4, THC/OPI/COC/AMP OR MET | DIO | 1995-10-26 |
| 6703 | 1893682870 | K945514 | LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG | LCX | 1995-02-10 |
| 6703 | 1122507152 | K944426 | BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE | JHI | 1994-10-25 |
| 6703 | 1482053906 | K943439 | ABUSIGN DOA4 | DKZ | 1995-02-22 |
| 6703 | 1082232301 | K930185 | OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP | CEP | 1993-03-04 |
| 6703 | 1384595502 | K926308 | LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST | LCX | 1993-01-26 |
| 6703 | 1096519563 | K925355 | BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST | LFX | 1994-07-12 |
| 6703 | 2051849489 | K251538 | Status™ COVID-19/Flu A&B | SCA | 2025-11-14 |
| 6703 | 1514101915 | K133474 | BIOSIGN FLU A + B, STATUS FLU A & B | PSZ | 2013-12-10 |
| 6703 | 2059332456 | K132465 | BIOSIGN FLU A + B, STATUS FLU A & B | PSZ | 2013-09-09 |
| 6703 | 1904823082 | K130650 | STATUS DS OXY | DJG | 2014-02-26 |
| 6703 | 1949950637 | K100817 | BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST | KHE | 2010-07-01 |
| 6703 | 1156383350 | K100341 | SPERMCHECK FERTILITY | POV | 2010-05-04 |
| 6703 | 1762973806 | K083746 | BIOSIGN FLU A+B | PSZ | 2010-11-10 |
| 6703 | 1574244115 | K082661 | BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A | GTY | 2008-10-06 |
| 6703 | 1331703814 | K073039 | SPERMCHECK VASECTOMY | POV | 2008-01-24 |
| 6703 | 1248144376 | K062575 | MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP | LAG | 2007-11-26 |
| 6703 | 1030224164 | K062565 | STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE | MKU | 2007-02-20 |
| 6703 | 1574584088 | K050955 | LIFESIGN DXPRESS, MODEL LSR2000 | JHI | 2006-01-23 |
| 6703 | 1322466813 | K040708 | STATUS FIRST STREP A | GTY | 2004-11-22 |
| 6703 | 1619970740 | K022946 | LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST | MMI | 2002-10-08 |
| 6703 | 2029682748 | K020439 | STATUS HCG SERUM/URINE | JHI | 2002-05-23 |
| 6703 | 1171406946 | K014193 | LIFESIGN DOA 4 (THC/OPI/COC/MET) | LDJ | 2002-05-23 |
| 6703 | 1860962622 | K014192 | LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET | MVO | 2002-05-23 |
| 6703 | 1817457579 | K014069 | LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC | DIO | 2002-06-10 |
| 6703 | 1546583549 | K014067 | LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC | DIO | 2002-06-10 |
| 6703 | 1307782949 | K014066 | LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC | LDJ | 2002-06-10 |
| 6703 | 1044153885 | ||||
| 6703 | 1055169842 | ||||
| 6703 | 1281923168 | ||||
| 6703 | 1638315886 | ||||
| 6703 | 1706604814 | ||||
| 6703 | 1727924172 | ||||
| 6703 | 1967489177 | ||||
| 6703 | 2027899543 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DIO | 7 | 2002-06-10 |
| GTY | 4 | 2008-10-06 |
| DJG | 3 | 2014-02-26 |
| PSZ | 3 | 2013-12-10 |
| LAG | 3 | 2007-11-26 |
| JHI | 3 | 2006-01-23 |
| MMI | 3 | 2002-10-08 |
| LDJ | 3 | 2002-06-10 |
| DKE | 3 | 1999-07-06 |
| DIS | 3 | 1999-04-15 |
| POV | 2 | 2010-05-04 |
| JXM | 2 | 1999-04-15 |
| DJR | 2 | 1999-04-15 |
| DHA | 2 | 1997-12-24 |
| CEP | 2 | 1996-11-29 |
| DKZ | 2 | 1995-04-13 |
| LCX | 2 | 1995-02-10 |
| SCA | 1 | 2025-11-14 |
| KHE | 1 | 2010-07-01 |
| MKU | 1 | 2007-02-20 |
| MVO | 1 | 2002-05-23 |
| JHT | 1 | 1999-05-28 |
| LYR | 1 | 1998-09-22 |
| LFH | 1 | 1998-08-25 |
| LFG | 1 | 1998-03-13 |
| KTN | 1 | 1997-02-04 |
| LCM | 1 | 1996-05-31 |
| LAF | 1 | 1996-04-25 |
| DDR | 1 | 1995-08-14 |
| LFX | 1 | 1994-07-12 |
Princeton BioMeditech Corp.
Princeton BioMeditech Corp.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
PRINCETON BIOMEDITECH CORP.
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