Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3024756665

FEI Number

3024756665

Entity Name

Access Bio, Inc.

City/State/Country

Monroe Township, NJ, US

Establishment Address

7 Fitzgerald Ave, Monroe Township, NJ 08831, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Access Bio, Inc. (Owner Number: 10028116)

Owner / Operator Contact Address

7 Fitzgerald Ave, Monroe Township, NJ 08831, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241915

PMA Number

N/A

All Registered Proprietary Names

CareSuperb COVID-19/Flu A&B Antigen Combo External Control CareStart COVID-19 Antigen on/go COVID-19 Antigen SelfTest CareStart COVID-19 Antigen Home Test CareStart COVID-19 MDx RT-PCR CareStart COVID-19 Antibody External Controls CareStart COVID-19 IgM/IgG CareSuperb Mpox (Monkeypox) Antigen Rapid Test CareSuperb COVID-19/Flu A&B Antigen Combo Home Test CareSuperb COVID-19/Flu A&B Antigen Combo Test CareStart Dengue Combo NS1 & IgM/IgG CareStart Dengue NS1 CareStart Malaria Pf (HRP2) CareStart Malaria Pf (HRP2/pLDH) CareStart Malaria Pf/PAN (HRP2/pLDH) Combo CareStart Malaria PAN (pLDH) CareSuperb COVID-19 Antigen Home Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2026-06-05
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2020-10-09
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2020-07-08
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2020-04-20
QTU	Reagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen Tests	Unknown	Class N	N/A	2025-09-09
SCA	Multi-Analyte Respiratory Virus Antigen Detection Test	Microbiology	Class 2	866.3987	2025-09-22
OSU	Dengue Serological Reagents	Microbiology	Class 2	866.3945	2015-08-06
OAX	Plasmodium Spp. Detection Reagents	Microbiology	Class 2	866.3402	2025-12-10
QYT	Over-The-Counter Covid-19 Antigen Test	Microbiology	Class 2	866.3984	2025-12-24

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Access Bio, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K990531	Ortho-Clinical Diagnostics, Inc.	VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS	1999-03-12
K982637	Diagnostic Products Corp.	IMMULITE PSA CONTROL MODULE, MODEL LPSCM	1998-08-12
K012468	Dade Behring, Inc.	MODIFICATION TO N/T PROTEIN CONTROL SL	2001-09-04
K241317	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)	2024-09-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2023	Jiangsu Well Biotech Co., Ltd. No	N	Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Z-0004-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0005-2022	Abbott Molecular, Inc.	N	Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Z-0006-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0007-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024756665. Last updated year: 2026. Please use registration number 3024756665 when referencing this establishment in official correspondence.