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Home›USA›Gen-Probe Incorporated

Gen-Probe Incorporated

USA · San Diego
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Israel — 4 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
74510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 74 510(k), 122 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 1Class II 1
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
4active device licences
Class II 4
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 States0 registration records, 74 510(k), 122 PMA, 8 excluded
Brazil2 confirmed, 0 excluded
Canada4 confirmed, 0 excluded
Manufacturer names merged into this page: GEN-PROBE PRODESSE, INC. · GEN-PROBE INCORPORATED
Same-named companies — This database also contains companies with near-identical names: Gen-Probe Prodesse, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
San Diego

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

11985
51986
61987
21988
61989
171990
11991
31992
41994
11996
12001
12002
22003
32005
52006
22007
22010
22011
12012
92013

Registration details (sample)

MarketIdentifierNameClass / date
USK132251APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)2013-10-17
USK132238PROPARAFLU+ ASSAY2013-08-26
USK132237PRODESSE PROFAST+ ASSAY2013-08-26
BR10269410445LUMINÔMETRO HC + PROCLEIXClass II
BR80144959005PROCLEIX TCSClass I
CA68997PROFLU-1 LC REAL TIME ASSAYClass II
CA68998HEXAPLEX PLUS ASSAYClass II
CA69000PROFLU-1 REAL TIME ASSAYClass II

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