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TECHLAB, INC.

USA · Blacksburg

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 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 6Class II 4Class III 0

plus 48 registration records and 36 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

4 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

3active device licences

Class II 3

27 including historic records

TWTaiwanTFDA

10valid device licences

Class I 10

SGSingaporeHSA SMDR

2device registrations

CLASS B 1CLASS C 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

3active ARTG entries

IVD Class 2 2IVD Class 3 1

HKHong KongMDACS

5valid listings

IVD B 5

ILIsraelAMAR

3registrations

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 States48 registration records, 36 510(k), 0 PMA, 1 excluded

Brazil3 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: TECHLAB, INC. · TECHLAB INC. · TECHLAB, INC

FDA 510(k) clearances by year

11992

21993

21994

21995

41996

11997

11998

11999

12000

12001

52003

12004

32005

22006

12009

22017

42018

22019

FDA listed device types

showing 8 of 10

Antigens, All Types, Escherichia Coli 1Campylobacter Spp. 1Reagents, Clostridium Difficile Toxin 1Antigen, C. Difficile 1Lactoferrin, Antigen, Antiserum, Control 1Helicobacter Pylori 1Cryptosporidium Spp. 1Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K191442	Campylobacter Chek	2019-06-20
US	K191456	Campylobacter Quik Chek	2019-06-20
US	K181379	H. PYLORI QUIK CHEK	2018-08-21
BR	80001590004	E. HISTOLYTICA II	Class II
BR	80001590005	GIARDIA II	Class II
BR	80001590006	CRYPTOSPORIDIUM II	Class II
CA	102908	QUICKVUE TLI CAMPYLOBACTER TEST	Class II
CA	102939	QUICKVUE TLI LACTOFERRIN TEST	Class II
CA	103623	QUICKVUE TLI H. PYLORI STOOL ANTIGEN TEST	Class II

TECHLAB, 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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