PRO AS-PA M B2 SET

FDA UDI

NAKANISHI INC.·04560264506039·

PRO AS-DYNALED SU M4 KIT

FDA UDI

NAKANISHI INC.·04560264534827·

PRO AS-PAX TU M4 KIT

FDA UDI

NAKANISHI INC.·04560264504363·

AFB (Europe) Ltd

Authorized representative

🇮🇪 Ireland·1 Manufacturer

Nouvag Dental- und Medizintechnik GmbH

Authorized representative

🇩🇪 Germany·1 Manufacturer

Assay, Nucleic Acid Amplification, Bacillus Anthracis

FDA classification

FDA Class 2 ·Assay, Nucleic Acid Amplification, Bacillus Anthracis

LFB BIOMEDICAMENTS

System producer

🇫🇷 France

Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control

Chromatographic Derivative, Total Lipids

FDA classification

FDA Class 1 ·Chromatographic Derivative, Total Lipids

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)

FB Dermatology S.r.l.

Importer

🇮🇹 Italy

IT328004

Certificate

MDR QMS·FB VISION S.p.A.·BUREAU VERITAS ITALIA S.P.A.

SureSmile®

FDA UDI

DENTSPLY SIRONA ORTHODONTICS INC.·D746ORX000011·SureSmile Dr Starter Kit

Modified Grocott's Methenamine Silver (Periodic Acid) Kit

FDA registration

FISHER SCIENTIFIC CO., LLC.·1 product·🇺🇸 United States

Modified Grocott's Methenamine Silver (Periodic Acid) Kit

FDA registration

REMEL, INC.·1 product·🇺🇸 United States

CALXYL® SUSPENSION

Basic UDI-DI

EU MDR · Eu Md Class 2a ·OCO-Präparate Herstellung und Vertrieb von pharmazeutischen Produkten GmbH·1 device

Revogene® GBS LB

FDA UDI

Meridian Bioscience Canada Inc·00628055344117·The Revogene® GBS LB assay performed on the Rev...

GenePOC™ GBS LB

FDA UDI

GenePoc Inc·00628055344018·The GenePOC™ GBS LB assay performed on the revo...

Revogene GBS LB

FDA UDI

MERIDIAN BIOSCIENCE, INC.·00840733102363·The Revogene GBS LB assay performed on the Revo...

Influenza A Virus Subtype Differentiation Nucleic Acid Assay

FDA classification

FDA Class 2 ·Influenza A Virus Subtype Differentiation Nucleic Acid Assay