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SCANTIBODIES LABORATORY, INC.

USA · Santee

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 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 7Class II 5Class III 0unclassified 3

plus 19 registration records and 19 510(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

1 including historic records

TWTaiwanTFDA

0valid device licences

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 States19 registration records, 19 510(k), 0 PMA, 2 excluded

Manufacturer names merged into this page: SCANTIBODIES LABORATORY INC. · SCANTIBODIES LABORATORY, INC.

FDA 510(k) clearances by year

21995

41996

11997

12000

12001

12002

12003

52005

32006

FDA listed device types

showing 8 of 15

Plate, Silica Gel, Tlc 1Container, Specimen, Non-Sterile 1Campylobacter Spp. 1Multi-Analyte Controls, All Kinds (Assayed) 1Reagents, Clostridium Difficile Toxin 1Antigens, Cf (Including Cf Control), Influenza Virus A, B, C 1Applicator, Absorbent Tipped, Sterile 1Covid-19 Multi-Analyte Antigen Device 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K060578	CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)	2006-08-30
US	K060420	MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002	2006-03-01
US	K060348	MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT	2006-02-27

SCANTIBODIES LABORATORY, 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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