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Home›USA›Abbott Rapid Diagnostics

Abbott Rapid Diagnostics

USA · San Diego
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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
5510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
9registered devices
Class I 5Class II 4
22 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
3active device licences
Class II 3
13 including historic records
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 States0 registration records, 5 510(k), 0 PMA, 30 excluded
Brazil9 confirmed, 5 excluded
Saudi Arabia0 confirmed, 2 excluded
Canada3 confirmed, 5 excluded
Manufacturer names merged into this page: ABBOTT RAPID DIAGNOSTICS ULC · ABBOTT RAPID DX GALWAY · ABBOTT RAPID DIAGNOSTICS JENA GMBH
Same-named companies — This database also contains companies with near-identical names: ABBOTT RAPID DIAGNOSTICS ULC. 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

11998 · K981770
12001 · K003809
12002 · K020716
12004 · K033566
12017 · K171650

Registration details (sample)

MarketIdentifierNameClass / date
USK171650Alere Afinion HbA1c and ACR on Afinion 2 analyzer2017-11-21
USK033566MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-70622004-05-17
USK020716RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)2002-05-06
BR10071779007Safety Lancet SuperClass II
BR10071770934Curativo adesivo - Penso adesivoClass I
BR10071770935Sistema de coleta de sangue capilarClass I
CA86471CLEARVIEW MONOClass II
CA86473HCG COMBO CASSETTE 20/10Class II
CA86474CLEARVIEW H.PYLORIClass II

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