Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·Rapid fFN for the TLiIQ System

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·Rapid fFN for the TLiIQ System

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·RAPID FFN FOR THE TLIIQ SYSTEM

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·RAPID FFN CONTROL KIT

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·FULLTERM FETAL FIBRONECTIN TEST

N/A

FDA UDI

HARDY DIAGNOSTICS·00816576026388·BBE / LKV, 15x100mm Biplate, 10ml/10ml. Hardy ...

AnaeroGRO

FDA UDI

HARDY DIAGNOSTICS·00816576024445·DuoPak A, BRU with Hemin and Vitamin K, Monopla...

AnaeroGRO

FDA UDI

HARDY DIAGNOSTICS·00816576024490·MultiPak B, BRU with Hemin and Vitamin K, Monop...

AnaeroGRO

FDA UDI

HARDY DIAGNOSTICS·00816576024452·MultiPak A, BRU with Hemin and Vitamin K, Monop...

Enzyme Immunoassay, Fetal Fibronectin

FDA classification

FDA Class 3 ·Enzyme Immunoassay, Fetal Fibronectin

Lyv Healthcare

Manufacturer

🇫🇷 France·1 Basic UDI-DI·2 Devices

LKC Technologies

Manufacturer

🇺🇸 United States·3 Importers

Alinity m BKV AMP Kit

FDA registration

ABBOTT MOLECULAR, INC.·3 products·🇺🇸 United States

Alinity m BKV Amplification Reagent Kit

FDA registration

ABBOTT MOLECULAR, INC.·1 product·🇺🇸 United States

cobas® EBV/BKV Control Kit

FDA registration

ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States

cobas® EBV/BKV Control Kit

FDA registration

ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States

cobas® EBV/BKV Control Kit

FDA registration

ROCHE DIAGNOSTICS INTERNATIONAL LTD.·1 product·🇨🇭 Switzerland

KIT COBAS 6800/8800 BKV 192T IVD

FDA registration

ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States

KIT COBAS 6800/8800 BKV 192T IVD

FDA registration

ROCHE MOLECULAR SYSTEMS, INC.·1 product·🇺🇸 United States

Lev-EL Heart Diagnostics Ltd.

Manufacturer

🇮🇱 Israel