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Sign in to claim this brandPRINCETON BIOMEDITECH CORP.
United States·US-MF-000048310
Last updated September 17, 2026
What PRINCETON BIOMEDITECH CORP. makes
Princeton Biomeditech Corp. manufactures in vitro diagnostic (IVD) test kits for rapid immunochromatographic detection of substances and biomarkers in clinical settings. These include kits for cocaine and cocaine metabolites, cannabinoids and cannabinoid metabolites, opiates and opiate metabolites, total human chorionic gonadotropin (hCG), phencyclidine (PCP), methamphetamine, amphetamine, and beta-haemolytic Group A Streptococcus antigen.
The company's devices are classified as Class I, Class II, IVD General, N, and U, and are listed in regulatory databases including EUDAMED, FDA 510(k), and FDA UDI. Princeton Biomeditech Corp. is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Princeton Biomeditech Corp. manufacture?
Princeton Biomeditech Corp. manufactures in vitro diagnostic (IVD) test kits for rapid immunochromatographic detection of substances and biomarkers in clinical settings, including kits for cocaine and cocaine metabolites, cannabinoids and cannabinoid metabolites, opiates and opiate metabolites, total human chorionic gonadotropin (hCG), phencyclidine (PCP), methamphetamine, amphetamine, and beta-haemolytic Group A Streptococcus antigen.
Where is Princeton Biomeditech Corp. based?
Princeton Biomeditech Corp. is based in the United States, as stated in the provided device data under the COUNTRY field.
Which regulatory registries list devices from Princeton Biomeditech Corp.?
Devices from Princeton Biomeditech Corp. are listed in EUDAMED, FDA 510(k), and FDA UDI, as specified in the LISTED IN field of the device data.
How are the devices from Princeton Biomeditech Corp. classified?
The devices from Princeton Biomeditech Corp. are classified as Class I, Class II, IVD General, N, and U, according to the DEVICE CLASSES field in the provided data.
AI-generated from registry data and not verified by a human reviewer.
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 1 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Accusay Mono | ACC-M001P | EUDAMED | IVD General | Active |
| AccuSign® MET card | DOA-202-35-02 | FDA UDI | Class II | Active |
| StatusFirst™ hCG S/U card | BSP-122-35-02 | FDA UDI | Class II | Active |
| LifeSign® MI Troponin I card | LSC-130-20-00 | FDA UDI | Class II | Active |
| LifeSign® MI CK-MB/Myo/TnI card | LSC-300-20-00 | FDA UDI | Class II | Active |
| Status DS™ 4/MET stick | DOA-141-10-00 | FDA UDI | Class II | Active |
| Status Flu A+B Nasal Wash/Aspirate Kit | BSP-510AS-04 | FDA UDI | Class I | Active |
| Status™ H. pylori card | BSP-406WB-25-02 | FDA UDI | Class I | Active |
| Status AccuStrep A card | BSP-181-25-01 | FDA UDI | Class I | Active |
| Status DS™ 4/MET stick | DOA-141-35-00 | FDA UDI | Class II | Active |
| Status hCG card | BSP-121-35-01 | FDA UDI | Class II | Active |
| Status Flu A & B | BSP-510-05-00 | FDA UDI | Class I | Active |
| Status™ COVID-19 Antigen Rapid Test for Home Use | BSP-512-25-00 | FDA UDI | N | Active |
| BioStrep® A | BSP-185-30-04 | FDA UDI | Class I | Active |
| OvuSign® LH card | OSH-143-35-01 | EUDAMEDFDA UDI | Class I | Active |
| BioSign® hCG card | BSP-121-35-07 | FDA UDI | Class II | Active |
| AccuSign® COC card | DOA-200-10-02 | FDA UDI | Class II | Active |
| LifeSign® MI StatusFirst CK-MB/Myo/TnI card | LSC-300-01-00 | FDA UDI | Class II | Active |
| AccuSign® DOA 8 card | DOA-280-25-04 | FDA UDI | U | Active |
| Status DS™ 9 card | DOA-290-25-01 | FDA UDI | Class II | Active |
| Status DS™ TCA card | DOA-209-35-01 | FDA UDI | Class II | Active |
| Status Strep A Plus | BSP-185-50-01 | FDA UDI | Class I | Active |
| Status Flu A+B card | BSP-510-22-01 | FDA UDI | Class I | Active |
| Status hCG card | BSP-121-12-00 | FDA UDI | Class II | Active |
| AccuSign® DOA 2 THC/COC card | DOA-221-35-02 | FDA UDI | Class II | Active |
| AccuSign® TCA card | DOA-209-35-02 | FDA UDI | Class II | Active |
| BioSign® Strep A card | BSP-181-25-02 | FDA UDI | Class I | Active |
| Status DS™ 9 card | DOA-290-10-01 | FDA UDI | Class II | Active |
| Status Stick™ 5/MET Stick | DOA-151-35-00 | FDA UDI | Class II | Active |
| AccuSign® MET card | DOA-202-10-02 | FDA UDI | Class II | Active |
| AccuSign® DOA 4/MET card | DOA-241-35-02 | FDA UDI | Class II | Active |
| Status Strep A Flip | BSP-182-25-00 | FDA UDI | Class I | Active |
| Status™ hCG S/U card | BSP-120S-12-00 | FDA UDI | Class II | Active |
| Status Strep A Flip | BSP-182-12-00 | FDA UDI | Class I | Active |
| BioSign® RC hCG S/U card | BSP-122-35-01 | FDA UDI | Class II | Active |
| BioSign® Mono card | BSP-402WB-35-01 | FDA UDI | Class II | Active |
| Status Strep A Plus | BSP-185-05-00 | FDA UDI | Class I | Active |
| AccuSign® MTD card | DOA-208-35-02 | FDA UDI | Class II | Active |
| PBM Cardiac Marker Control | LSC-300C-01 | FDA UDI | N/A | Active |
| Status™ H. pylori card | BSP-406WB-30-07 | FDA UDI | Class I | Active |
| AccuSign® DOA 2 THC/COC card | DOA-221-10-02 | FDA UDI | Class II | Active |
| AccuSign® OPI card | DOA-203-10-02 | FDA UDI | Class II | Active |
| Status Mono Waived card | BSP-402WB-10-03 | FDA UDI | Class II | Active |
| Status DS™ 10 card | DOA-300-10-01 | FDA UDI | Class II | Active |
| AccuSign® DOA 4/AMP card | DOA-240-35-02 | FDA UDI | Class II | Active |
| Status DS™ 8 card | DOA-280-25-01 | FDA UDI | Class II | Active |
| Status™ COVID-19 Antigen Rapid Test for Home Use | BSP-512-02-00 | FDA UDI | N | Active |
| AccuSign® DOA 5/AMP card | DOA-250-35-02 | FDA UDI | U | Active |
| Status iFOBT Mailers with Collection Tubes Kit | BSP-300-TM-01 | FDA UDI | N/A | Active |
| Status™ hCG strip | BXI-113-35-00 | FDA UDI | 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.
There are 4 recall records for Princeton Biomeditech Corp., with the earliest initiated on 2012-03-09 and the most recent on 2024-08-23. The statuses of these recalls include open, classified, and terminated. The reasons given for the recalls include customer complaints of false negative hCG test results when running patient urine samples, and reports of dual positive (Flu A + Flu B positive) results being encountered.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| 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. |