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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX HBc lgM assay and Control

POSEIDON

FDA registration

Kreatech biotechnology b.v.·1 product·🇳🇱 Netherlands

40V033V495

FDA registration

Kreatech biotechnology b.v.·1 product·🇳🇱 Netherlands

NA

FDA UDI

Synthes GmbH·00845384014928·2.47 mm x 30.3 mm Fluted Spiral Router, 4-Serie...

N/A

FDA UDI

ORIGIO INC.·20888937904653·HOLDING MICROPIPETS

NA

FDA UDI

Synthes GmbH·00845384014225·5 mm x 16.2 mm Fluted Drum. Use with LONG-HD-G1...

Trulife

FDA UDI

TRULIFE LIMITED·00645517319643·CASH APE HING PUB LG BACKPD 30

NA

FDA UDI

Synthes GmbH·00845384016120·2.3 MM FLUTED MATCHSTICK,USE WITH QD8-G1, SHORT...

NA

FDA UDI

Synthes GmbH·00845384015697·1.5 mm x 7.5 mm Cylindrical Carbide Drum, Exten...

NA

FDA UDI

Synthes GmbH·00845384013938·4 MM DIAMOND BALL,USE WITH QD8-G1, SHORT-G1, QD...

TOBOGGAN ARM/LEG GUARD LG 2/CA

FDA UDI

ALIMED, INC.·00733657259469·

Motion Medical Distributing

FDA UDI

Haslam Medical, Inc.·15060498450703·#1243 IV Start Kit Contents: (1) IV Dressing, (...

ACCURUN 141 Rubella IgM Positive Control

Device

EU IVDD · Eu Ivd Annex 2 List B ·LGC Clinical Diagnostics, Inc.·On the market

Multichem ID Rubella IgM Positive Control

Device

EU IVDD · Eu Ivd Annex 2 List B ·LGC Clinical Diagnostics, Inc.·On the market

ACCURUN 140 Rubella IgG Positive Control

Device

EU IVDD · Eu Ivd Annex 2 List B ·LGC Clinical Diagnostics, Inc.·On the market

ACCURUN 136 Toxoplasma IgM Positive Control

Device

EU IVDD · Eu Ivd Annex 2 List B ·LGC Clinical Diagnostics, Inc.·On the market

ACCURUN 135 Toxoplasma IgG Positive Control

Device

EU IVDD · Eu Ivd Annex 2 List B ·LGC Clinical Diagnostics, Inc.·On the market

ACCURUN 132 Borrelia burgdorferi IgM Positive Control

Device

EU IVDD · Eu Ivd General ·LGC Clinical Diagnostics, Inc.·On the market

ACCURUN 130 Borrelia burgdorferi IgG Positive Control

Device

EU IVDD · Eu Ivd General ·LGC Clinical Diagnostics, Inc.·On the market

ACCURUN 40 Anti-Measles, Mumps, Rubella, VZV Positive Control Series 5000

Device

EU IVDD · Eu Ivd Annex 2 List B ·LGC Clinical Diagnostics, Inc.·On the market