V8800 Critical Care Ventilator

FDA registration

Oricare Inc.·4 products·🇺🇸 United States

SentrySuite Product Line 2.7

FDA registration

Jaeger Medical America Inc.·4 products·🇺🇸 United States

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·LIAISON XL MUREX Anti-HBs; LIAISON XL MUREX Control Anti-HBs; LIAISON XL Murex Anti-HBs Verifiers

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Alinity i Anti-HBs Regent Kit, Alinity i Anti-HBs Calibrators, and Alinity i Anti-HBs Controls

Manual Wheelchair

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Hangzhou Enti Technology Co.,Ltd·1 device

LABELING CHANGE CANNABINOIDS DOUBLE ANTI. IN URINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT II ANTI-SS-B/LA ELISA

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA

FDA 510(k)

FDA Class 2 ·Immunology

READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT

FDA 510(k)

FDA Class 2 ·Hematology

OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER

FDA 510(k)

FDA Class 2 ·Anesthesiology

ORGENTEC ANTI-TG PIA (PIN IMMUNO ASSAY)

FDA 510(k)

FDA Class 2 ·Immunology

DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS)

FDA 510(k)

FDA Class 2 ·Immunology

BINDAZYME ANTI-B2 SCREEN EIA TEST KIT.

FDA 510(k)

FDA Class 2 ·Immunology

UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE

FDA 510(k)

FDA Class 2 ·Immunology

IS-ANTI-PR3 IGG ELISA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI.

FDA 510(k)

FDA Class 2 ·Dental

IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ

FDA 510(k)

FDA Class 2 ·Immunology

VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology