HomeUSAMORE DIAGNOSTICS, INC.

MORE DIAGNOSTICS, INC.

USA · Los Osos
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Hong Kong, Russia — 6 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
3listed device types
Class I 3Class II 0Class III 0
plus 6 registration records and 16 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
1 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class III 1
3 including historic records
TWTaiwanTFDA
4valid device licences
Class II 4
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
1valid listings
IVD B 1
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
1active registrations
Class 1 1
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 States6 registration records, 16 510(k), 0 PMA, 9 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: MORE DIAGNOSTICS INC. · MORE DIAGNOSTICS, INC.

Company information

Country
USA
City
Los Osos

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

51993
21994
31995
21997
21998
12005
12008

FDA listed device types

Enzyme Controls (Assayed And Unassayed) 1Multi-Analyte Controls, All Kinds (Assayed) 1Drug Specific Control Materials 1

Registration details (sample)

MarketIdentifierNameClass / date
USK072257MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL2008-01-30
USK050125RAP/TAC/CSA CONTROL - LEVEL 1,2,3,42005-03-18
USK982845CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-31998-08-21
CA75755RAP/TAC/CSA IMMUNOSUPPRESSANT CONTROLClass III

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