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MICROBIOLOGICS, INC.

USA · St. Cloud

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Taiwan, Australia, Israel — 5 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

7listed device types

Class I 6Class II 1Class III 0

plus 15 registration records and 18 510(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

13 including historic records

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

IVD Class 1 1IVD Class 2 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States15 registration records, 18 510(k), 0 PMA

Manufacturer names merged into this page: MICROBIOLOGICS, INC. · Microbiologics, Inc.

FDA 510(k) clearances by year

91995

11997

32018 · K182472

52019 · K190086

FDA listed device types

Kit, Quality Control For Culture Media 1Stains, Microbiologic 1Device, General Purpose, Microbiology, Diagnostic 1General Purpose Reagent 1Multi-Analyte Controls Unassayed 1Quality Control Slides 1Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K190086	Cepheid Xpert Respiratory Control Panel	2019-10-07
US	K191168	Cepheid Xpert SA Nasal Complete Control Panel	2019-06-25
US	K191172	Cepheid Xpert MRSA NxG Control Panel	2019-06-20

MICROBIOLOGICS, 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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