MODIFICATION OF MONO-PLUS(TM)

FDA 510(k)

FDA Class 2 ·Immunology

TROJAN PLUS LUBRI. LATEX CONDOMS (MODIFIED LABEL)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BACTIGEN GROUP B STREPTOCOCCUS TEST

FDA 510(k)

FDA Class 1 ·Microbiology

TROJAN RIBBED LUBRI. LATEX CONDOMS MODIFIED LABEL

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TROJAN EXTRA LARGE LATEX CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

POSITIVE AND NEGATIVE HCG SERUM CONTROLS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MONO-LATEX (TM) SLIDE TEST

FDA 510(k)

FDA Class 2 ·Immunology

VIROGEN RUBELLA SLIDE TEST

FDA 510(k)

FDA Class 2 ·Microbiology

TBD AT-HOME PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BACTIGEN(R) H. INFLUENZAE TYPE B

FDA 510(k)

FDA Class 2 ·Microbiology

Laser BCR modification kit for UCU

Device

EU IVDR · Eu Ivd Class A ·Hitachi High-Tech Corporation·On the market

Laser BCR modification kit for OBS

Device

EU IVDR · Eu Ivd Class A ·Hitachi High-Tech Corporation·On the market

Laser BCR modification kit for AOB

Device

EU IVDR · Eu Ivd Class A ·Hitachi High-Tech Corporation·On the market

Laser BCR modification kit for ACU

Device

EU IVDR · Eu Ivd Class A ·Hitachi High-Tech Corporation·On the market

Laser BCR modification kit for RFX

Device

EU IVDR · Eu Ivd Class A ·Hitachi High-Tech Corporation·On the market

Laser BCR modification kit for URF

Device

EU IVDR · Eu Ivd Class A ·Hitachi High-Tech Corporation·On the market

Laser BCR modification kit for BRF

Device

EU IVDR · Eu Ivd Class A ·Hitachi High-Tech Corporation·On the market

Leica FL800

FDA registration

LEICA MICROSYSTEMS (SCHWEIZ) AG·2 products·🇨🇭 Switzerland

DMI6000 B

FDA registration

LEICA MICROSYSTEMS CMS GMBH·1 product·🇩🇪 Germany

Leica M525 F20

FDA registration

LEICA MICROSYSTEMS (SCHWEIZ) AG·1 product·🇨🇭 Switzerland