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Home›USA›BIOCHEMICAL DIAGNOSTICS, INC.

BIOCHEMICAL DIAGNOSTICS, INC.

USA · Edgewood
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Australia — 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
3listed device types
Class I 3Class II 0Class III 0
plus 7 registration records and 7 510(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
3active device licences
Class II 3
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IVD Class 2 2
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 States7 registration records, 7 510(k), 0 PMA, 10 excluded
Brazil0 confirmed, 5 excluded
Canada3 confirmed, 1 excluded
Manufacturer names merged into this page: BIOCHEMICAL DIAGNOSTICS, INC.
Same-named companies — This database also contains companies with near-identical names: Biochemical Diagnostic, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Edgewood

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

11984
11991
11992
12005
12012
12013
12016

FDA listed device types

Single (Specified) Analyte Controls (Assayed And Unassayed) 1Drug Mixture Control Materials 1Multi-Analyte Controls Unassayed 1

Registration details (sample)

MarketIdentifierNameClass / date
USK153474Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series2016-02-23
USK132688SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ2013-12-16
USK121122DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL2012-07-03
CA6670DETECTABUSE LIQUID CONTROL URINEClass II
CA9206VMA -SKREENClass II
CA11465STEROID - SKREENClass II

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