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PRINCETON 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
LinkedIn: —
Facebook: —
Email: [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 2 of 5

Device	Model / Reference	Registries	Class	Status
Status Flu A+B Validation Kit	BSP-510-22-08	FDA UDI	Class I	Active
BioSign® Rubella card	BSP-171-35-01	FDA UDI	Class II	Active
StatusFirst™ 5/MET card	DOA-251-25-02	FDA UDI	U	Active
Status Flu Controls	BSP-510C-02	FDA UDI	N/A	Active
BioSign Flu Controls	BSP-510C-03	FDA UDI	N/A	Active
BioSign® H. pylori card	BSP-406WB-35-01	FDA UDI	Class I	Active
BioStrip® P	BXI-113-00-00	FDA UDI	Class II	Active
AccuSign® DOA 5/AMP card	DOA-250-10-01	FDA UDI	U	Active
BioSign Mono card	BSP-402WB-25-06	FDA UDI	Class II	Active
AccuSign® Nicotine card	DOA-217-35-00	FDA UDI	Class I	Active
AccuSign® OPI card	DOA-203-35-02	FDA UDI	Class II	Active
AccuSign® MET 500 card	DOA-202E-35-00	FDA UDI	Class II	Active
BioStrip® P	BXI-113-25-02	FDA UDI	Class II	Active
AccuSign® TCA card	DOA-209-10-02	FDA UDI	Class II	Active
Status™ H. pylori card	BSP-406WB-10-02	FDA UDI	Class I	Active
AccuSign® BZO card	DOA-207-10-02	FDA UDI	Class II	Active
BioSign® hCG S/U card	BSP-120S-35-04	FDA UDI	Class II	Active
AccuSign® BAR card	DOA-206-10-02	FDA UDI	Class II	Active
Status Strep A Flip	BSP-182-05-00	FDA UDI	Class I	Active
BioSign® Mono card	BSP-402WB-10-02	FDA UDI	Class II	Active
AccuSign® AMP card	DOA-204-10-02	FDA UDI	Class II	Active
Status iFOBTest	BSP-300-05-00	FDA UDI	Class II	Active
AccuSign® MTD card	DOA-208-10-02	FDA UDI	Class II	Active
Status iFOBT Test Device and Sample Collection Tubes Refill Kit	BSP-300-DT-00	FDA UDI	Class II	Active
Status iFOBTest Device Refill	BSP-300-D	FDA UDI	Class II	Active
AccuSign® AMP card	DOA-204-35-02	FDA UDI	Class II	Active
StatusFirst™ 10 card	DOA-300-25-06	FDA UDI	Class II	Active
Status BTA Card	BSP-307-10-00	FDA UDI	Class II	Active
AccuSign® DOA 5/MET card	DOA-251-10-02	FDA UDI	Class II	Active
Status iFOBTest	BSP-300-30-00	FDA UDI	Class II	Active
BioSign® hCG S/U card	BSP-120S-10-01	FDA UDI	Class II	Active
BioStrip® P	BXI-113-25-01	FDA UDI	Class II	Active
BioSign® H. pylori card	BSP-406WB-30-05	FDA UDI	Class I	Active
LifeSign® MI StatusFirst CK-MB/Myo/TnI card	LSC-300-20-02	FDA UDI	Class II	Active
AccuSign® BAR card	DOA-206-35-02	FDA UDI	Class II	Active
Status iFOBTest Control Kit	BSP-300-C-01	FDA UDI	N/A	Active
Status DS™ controls	21000	FDA UDI	N/A	Active
AccuSign® THC card	DOA-201-10-02	FDA UDI	Class II	Active
BioSign® hCG card	BSP-121-10-01	FDA UDI	Class II	Active
AccuSign® PCP card	DOA-205-10-02	FDA UDI	U	Active
Status Strep A strip	BSP-185-12-00	FDA UDI	Class I	Active
BioSign Flu A+B Nasal Wash/Aspirate Kit	BSP-510AS-07	FDA UDI	Class I	Active
Status™ Nicotine card	DOA-217-35-01	FDA UDI	Class I	Active
Status™ hCG S/U card	BSP-120S-35-01	EUDAMEDFDA UDI	Class II	Active
AccuSign® THC card	DOA-201-35-02	FDA UDI	Class II	Active
BioStrep® A	BSP-185-30-06	FDA UDI	Class I	Active
Status hCG controls	BSP-121C-00	FDA UDI	N/A	Active
BioSign® hCG card	BSP-121-35-03	FDA UDI	Class II	Active
Status H. pylori control	BSP-406C-00	FDA UDI	N/A	Active
Status BTA Card	BSP-307-25-00	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Medical Technology Promedt Consulting GmbH DE

Importers

Not available yet.

Notified Bodies

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Authorities

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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.