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ALFA SCIENTIFIC DESIGNS, INC.

USA · Poway

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, Israel — 7 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

39listed device types

Class I 5Class II 31Class III 0unclassified 3

plus 48 registration records and 43 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

13registered devices

Class II 13

17 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

4active device licences

Class II 4

13 including historic records

TWTaiwanTFDA

4valid device licences

Class I 1Class II 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

1active ARTG entries

IVD Class 2 1

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 States48 registration records, 43 510(k), 0 PMA, 16 excluded

Brazil13 confirmed, 4 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada4 confirmed, 1 excluded

Manufacturer names merged into this page: ALFA SCIENTIFIC DESIGNS, INC. · ALFA SCIENTIFIC DESIGNS INC.

FDA 510(k) clearances by year

51999

102000

122001

62002

12003

12004

12006

22007

12010

12013

12016

22018

FDA listed device types

showing 8 of 39

Test, Follicle Stimulating Hormone (Fsh), Over The Counter 1Drug Mixture Control Materials 1Radioimmunoassay, Luteinizing Hormone 1Antigens, All Groups, Streptococcus Spp. 1Helicobacter Pylori 1Kit, Test, Pregnancy, Hcg, Over The Counter 1Enzyme Immunoassay, Opiates 1Thin Layer Chromatography, Tricyclic Antidepressant Drugs 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K173303	INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)	2018-02-23
US	K173212	Instant-view-PLUS immunochemical Fecal Occult Blood Test	2018-02-15
US	K152122	Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)	2016-06-24
BR	80524900017	Instant View® Teste de Detecção de Múltiplas Drogas de Abuso na Urina	Class II
BR	80524900018	Instant-View Teste de Urina para Múltiplas Drogas (Painel)	Class II
BR	80524900020	Instant-View Teste de Urina para Múltiplas Drogas (Painel)	Class II
CA	66959	INSTANT-VIEW MULTI-DRUG SCREEN URINE TESTS	Class II
CA	79540	INSTANT-VIEW TEST DRUG SCREEN	Class II
CA	104070	INSTANT-VIEW MULTI-DRUG OF ABUSE URINE CUP TEST	Class II

ALFA SCIENTIFIC DESIGNS, 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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