10,000 results · 94ms · Sources: EU EUDAMED, US FDA

VITROS XT TRIG-CHOL Slides

FDA registration
ORTHO-CLINICAL DIAGNOSTICS, INC.·2 products·🇺🇸 United States

truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·KRONOS LV-T CRT-D & LUMAX VR/DR/HF (-T) ICDS & CDT-DS

CAPILLARYS 3 & MC SWITCH RACK FOR CDT (1)

Device
EU IVDR · Eu Ivd Class A ·sebia·On the market

PTS Panels® Triglycerides Test Strips

FDA UDI
POLYMER TECHNOLOGY SYSTEMS, INC.·00381931716018·PTS Panels® Triglycerides test strips are in vi...

VITROS

FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750031764·VITROS XT Chemistry Products TRIG-CHOL Slides

ClinRep® Complete Kit for CDT (Carbohydrate-deficient Transferrin) in Serum

Device
EU IVDR · Eu Ivd Class B ·RECIPE Chemicals + Instruments GmbH·On the market·32 countries

Sekisui Diagnostics P.E.I. Inc.

FDA registration
Sekisui Diagnostics P.E.I. Inc.·3 products·🇨🇦 Canada

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·TVL(TM) LEAD SYSTEM

ClinRep® Complete Kit for CDT (Carbohydrate-deficient Transferrin) in Serum ON-LINE

Device
EU IVDR · Eu Ivd Class B ·RECIPE Chemicals + Instruments GmbH·On the market·32 countries

Construction Tape CDT

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Eurotape B.V.·9 devices

ClinRep® Complete Kit for CDT (Carbohydrate-deficient Transferrin) in Serum AUTOMATED ON-LINE

Device
EU IVDR · Eu Ivd Class B ·RECIPE Chemicals + Instruments GmbH·On the market·32 countries

CDT SAMPLES TREATMENT SOLUTION

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·sebia·1 device

ENZYMATIC TRIGLYCERIDE

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

TRIGLYCERIDES

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

TRIGLYCERIDES TEST

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

SPIN-CHEM TRIGLYCERIDES REAGENT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

WAKO L-TYPE TRIGLYCERIDE TEST

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

GLYCEROL KINASE

FDA 510(k)
FDA Class 1 ·Clinical Chemistry