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Access Bio, Inc.

USA · Monroe Township

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, South Korea — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

10listed device types

Class I 1Class II 5Class III 0unclassified 4

plus 10 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

1 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

IVD import 2

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States10 registration records, 7 510(k), 0 PMA, 50 excluded

Brazil0 confirmed, 3 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 7 excluded

Manufacturer names merged into this page: Access Bio, Inc. · ACCESS BIO, INC

FDA 510(k) clearances by year

32003 · K032159

12005 · K051925

12020 · K191514

22025 · K251604

FDA listed device types

showing 8 of 10

Multi-Analyte Controls, All Kinds (Assayed) 1Dengue Serological Reagents 1Multi-Analyte Respiratory Virus Antigen Detection Test 1Over-The-Counter Covid-19 Antigen Test 1Plasmodium Spp. Detection Reagents 1Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening 1Reagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen Tests 1Reagent, Coronavirus Serological 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251604	CareSuperb COVID-19/Flu A&B Antigen Combo Home Test	2025-08-22
US	K241915	CareSuperb COVID-19 Antigen Home Test	2025-01-29
US	K191514	CareStart Flu A&B Plus	2020-02-18

Access Bio, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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