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Sign in to claim this brandPRINCETON BIOMEDITECH CORP.
United States·US-MF-000048310
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 4242 , US Highway 1, Monmouth Junction, United States
- Website
- www.pbmc.com
- —
- —
- [email protected]
- Phone
- +1 732-274-1000
- PRRC Contact
- Young-A Kim
- EUDAMED SRN
- US-MF-000048310
- FDA FEI Number
- 2246703
- DUNS Number
- —
Catalogue (213)
Page 3 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| AccuSign® DOA 3 TH/O/C card | DOA-230-10-02 | FDA UDI | Class II | Active |
| Status™ hCG S/U card | BSP-120S-10-03 | FDA UDI | Class II | Active |
| AccuSign® DOA 4/AMP card | DOA-240-10-02 | FDA UDI | Class II | Active |
| Status iFOBTest Collection Tube Kit | BSP-300-TU-01 | FDA UDI | N/A | Active |
| PBM Cardiac Marker Control | LSC-301 | FDA UDI | N/A | Active |
| AccuSign® DOA 10 card | DOA-300-25-04 | FDA UDI | Class II | Active |
| Status DS™ 8 card | DOA-280-10-01 | FDA UDI | U | Active |
| Status hCG card | BSP-121-35-06 | FDA UDI | Class II | Active |
| Status™ COVID-19 Antigen Rapid Test for Home Use | BSP-512-01-00 | FDA UDI | N | Active |
| Status Mono Moderate Complex card | BSP-402WB-30-02 | FDA UDI | Class II | Active |
| BioSign Flu A+B card | BSP-510-10-00 | FDA UDI | Class I | Active |
| Status Mono Waived card | BSP-402WB-30-03 | FDA UDI | Class II | Active |
| StatusFirst™ Tn I card | LSC-131-20-00 | FDA UDI | Class II | Active |
| AccuSign® PCP card | DOA-205-35-02 | FDA UDI | U | Active |
| BioStrip® P | BXI-113-50-01 | FDA UDI | Class II | Active |
| Status Stick™ 5/MET Stick | DOA-151-10-00 | FDA UDI | U | Active |
| Status™ COVID-19/Flu Control | BSP-511C-00 | FDA UDI | N/A | Active |
| StatusFirst Mono controls | BSP-402C-00 | FDA UDI | N/A | Active |
| AccuSign® COC card | DOA-200-35-02 | FDA UDI | Class II | Active |
| Status DS™ 10 card | DOA-300-25-01 | FDA UDI | Class II | Active |
| BioSign Flu A+B card | BSP-510-25-01 | FDA UDI | Class I | Active |
| Status™ Mono card | BSP-402WB-25-00 | FDA UDI | Class II | Active |
| LifeSign® MI StatusFirst Troponin I card | LSC-130-01-00 | FDA UDI | Class II | Active |
| BioSign® iFOBTest | BSP-300-25-00 | FDA UDI | Class II | Active |
| BioSign® H. pylori card | BSP-406WB-10-01 | FDA UDI | Class I | Active |
| BioSign® Rubella card | BSP-171-10-01 | FDA UDI | Class II | Active |
| Status Flu A+B card | BSP-510-04-00 | EUDAMEDFDA UDI | Class I | Active |
| AccuSign® DOA 4/MET card | DOA-241-10-02 | FDA UDI | Class II | Active |
| BioSign® hCG S/U card | BSP-120S-35-09 | FDA UDI | Class II | Active |
| BioSign Flu A+B card | BSP-510-22-00 | FDA UDI | Class I | Active |
| BioSign® Strep A card | BSP-182-25-02 | FDA UDI | Class I | Active |
| Status Strep A strip | BSP-185-30-01 | FDA UDI | Class I | Active |
| AccuSign® BZO card | DOA-207-35-02 | FDA UDI | Class II | Active |
| LifeSign® MI Myo/TnI card | LSC-210-20-00 | FDA UDI | Class II | Active |
| AccuSign® DOA 5/MET card | DOA-251-35-02 | FDA UDI | U | Active |
| BioSign® hCG card | BSP-121-35-10 | FDA UDI | Class II | Active |
| AccuSign® DOA 3 TH/O/C card | DOA-230-35-02 | FDA UDI | Class II | Active |
| BioSign® Strep A Flip | BSP-182-25-03 | FDA UDI | Class I | Active |
| Dxpress Reader | LSR-2000 | FDA UDI | Class I | Active |
| BioSign® RC hCG S/U card | BSP-122-35-00 | EUDAMEDFDA UDI | Class II | Active |
| Accusign Doa2, Doa, Bar/Bzo, Biosign Doa2, Bar/Bzo, Status Ds Bar/Bzo, Syva Rapidtest D.a.u. 2 Bar/Bzo | K991082 | FDA 510(k) | Class II | Active |
| Biostrep A, Biosign Strep A, Statusfirst Strep A | K082661 | FDA 510(k) | Class I | Active |
| Abusign Doa4 | K943439 | FDA 510(k) | Class II | Active |
| Biosign Ifobtest, Biosign Fecal Occult Blood Test | K100817 | FDA 510(k) | Class II | Active |
| Accusign Bar-Rapid One-Step Barbiturate Assay | K962669 | FDA 510(k) | Class II | Active |
| Biosign Flu A + B, Status Flu A & B | K133474 | FDA 510(k) | Class II | Active |
| Abusign(tm) Doa 4, Doa, Thc/Opi/Coc/Amp Or Met, Biosign(tm) Doa 4, Thc/Opi/Coc/Amp Or Met | K945549 | FDA 510(k) | Class II | Active |
| Accusign Mop, Biosign Mop, Staus Ds Mop | K981771 | FDA 510(k) | Class II | Active |
| 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 | K983147 | FDA 510(k) | Class II | Active |
| Abusign Doa 3, Doa, Coc/Thc/Opi, Accusign Doa 3, Biosign Doa 3, Coc/Thc/Oopi | K954571 | FDA 510(k) | Class II | Active |
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FDA Recalls (4)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Aug 23, 2024 | Z-0259-2025 | — | open, classified | 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. |
| Mar 9, 2012 | Z-2306-2012 | — | terminated | There have been reports of dual positive (Flu A + Flu B positive) results being encountered. |
| Mar 9, 2012 | Z-2307-2012 | — | terminated | There have been reports of dual positive (Flu A + Flu B positive) results being encountered. |
| Mar 9, 2012 | Z-2308-2012 | — | terminated | There have been reports of dual positive (Flu A + Flu B positive) results being encountered. |