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Nichols Institute

USA · San Juan Capistrano

✓ 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

1listed device types

Class I 0Class II 0Class III 1

plus 1 registration records and 83 510(k), 1 PMA

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

49active device licences

Class II 45Class III 4

TWTaiwanTFDA

pendingnot queried

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 States1 registration records, 83 510(k), 1 PMA, 3 excluded

Canada49 confirmed, 0 excluded

Manufacturer names merged into this page: Quest Diagnostics Nichols Institute · NICHOLS INSTITUTE DIAGNOSTICS

Same-named companies — This database also contains companies with near-identical names: Nichols Institute Diagnostics, Quest Diagnostics Nichols Institute. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

21985

51986

21987

31988

11989

21990

51992

81993

11994

81995

61996

71997

21998

51999

22000

32001

22002

12003

52004

12005

FDA listed device types

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K050784	NICHOLS ADVANTAGE ALDOSTERONE ASSAY	2005-06-01
US	K042676	NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY	2004-12-17
US	K042689	NICHOLS ADVANTAGE CORTISOL	2004-12-09
CA	4969	NICHOLS CHEMILUMINESCENCE HCG	Class III
CA	4973	INSULIN LIKE GROWTH FACTOR (IGF-1) BY EXTRACTION	Class II
CA	4980	NICHOLS CHEMILUMINESCENCE INTACT PARATHYROID HORMONE (PTH)	Class II

Nichols Institute

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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