121 results · 8ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Automatic specific protein analyzer

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

Carbohydrate Antigen 242 (CA242) Assay Kit (Chemiluminescent Immunoassay)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

Carbohydrate Antigen 50 (CA50) Assay Kit (Chemiluminescent Immunoassay)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

Pro-Gastrin Releasing Peptide (proGRP) Assay Kit (Chemiluminescent Immunoassay)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

25-Hydroxyvitamin D (25-OH-VD) Assay Kit (Chemiluminescent Immunoassay)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

Alpha-Fetoprotein (AFP) Assay Kit (Chemiluminescent Immunoassay)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

α-L-Fucosidase (AFU) Assay Kit (CNPF Substrate Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

Cancer Antigen 72-4 (CA72-4) Assay Kit (Chemiluminescent Immunoassay)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

Neuron-Specific Enolase (NSE) Assay Kit (Chemiluminescent Immunoassay)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

Retinol Binding Protein (RBP) Assay Kit (Immunonephelometric Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody Assay Kit (Immunonephelometric Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

Antistreptolysin “O”(ASO) Assay Kit (Immunonephelometric Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

Full-Range C-Reactive Protein (fCRP) Assay Kit (Immunonephelometric Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

Immunoglobulin M (IgM) Assay Kit (Immunonephelometric Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

Rheumatoid Factor (RF) Assay Kit (Immunonephelometric Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

Serum Amyloid A Protein (SAA) Assay Kit (Immunonephelometric Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

Kappa Light Chains (κ-LC) Assay Kit (Immunonephelometric Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

Neutrophil Gelatinase-Associated Lipocalin (NGAL) Assay Kit (Immunonephelometric Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

Microalbuminuria (mALB)Assay Kit (Immunonephelometric Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

Antistreptolysin “O”(ASO)Assay Kit (Latex Immunoturbidimetric Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device