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Applied BioCode, Inc.

USA · Santa Fe Springs

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Taiwan — 2 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

15listed device types

Class I 3Class II 12Class III 0

plus 8 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

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 States8 registration records, 5 510(k), 0 PMA

Manufacturer names merged into this page: Applied BioCode, Inc.

FDA 510(k) clearances by year

12018 · K180041

22019 · K192485

12025 · K242877

12026 · K254139

FDA listed device types

showing 8 of 15

Internal Polymerase Chain Reaction Control, Not Assay Specific 1Colorimeter, Photometer, Spectrophotometer For Clinical Use 1Reagents, Specific, Analyte 1Parainfluenza Multiplex Nucleic Acid Assay 1Respiratory Virus Panel Nucleic Acid Assay System 1Human Metapneumovirus (Hmpv) Rna Assay System 1Mycoplasma Pneumoniae Dna Assay System 1Influenza A Virus Subtype Differentiation Nucleic Acid Assay 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254139	BioCode® Respiratory Pathogen Panel (RPP)	2026-05-01
US	K242877	BioCode Gastrointestinal Pathogen Panel (GPP)	2025-01-10
US	K192485	BioCode Respiratory Pathogen Panel (RPP)	2019-12-23

Applied BioCode, 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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