SARS-CoV-2 Fluorescent PCR Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·Maccura Biotechnology Co., Ltd. ·1 device

SARS-CoV-2 Fluorescent PCR Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·Maccura Biotechnology Co., Ltd. ·1 device

SARS-CoV-2 Fluorescent PCR Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·Maccura Biotechnology Co., Ltd. ·1 device

T.P.H. Pol-Intech Sp. z o.o.

Importer

🇵🇱 Poland·1 Manufacturer

POL EMS Agencja-Przedstawicielstwo, Bogdan Lewicki

Importer

🇵🇱 Poland

RAW-POL STEFAŃSKI SPÓŁKA KOMANDYTOWO-AKCYJNA

Importer

🇵🇱 Poland·1 Manufacturer

Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

FDA classification

FDA Class 2 ·Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

FDA classification

FDA Class 2 ·Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

Hab Gov Strategics Applied Technologies Limited

Authorized representative

🇲🇹 Malta·2 Manufacturers·5 Devices

STAT PROFILE

FDA UDI

NOVA BIOMEDICAL CORPORATION·00385480534185·Remanufacture PRIME CCS Analyzer

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Roche cobas EGFR Mutation Test, Roche cobas DNA Sample Preparation Kit

Suture, Nonabsorbable, Synthetic, Polyamide

FDA Pre-Market Approval

FDA Class 2 ·ETHILON/NUROLON NYLON SUTURES

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS EGFR MUTATION TEST

Suture, Nonabsorbable, Synthetic, Polyester

FDA Pre-Market Approval

FDA Class 2 ·DACRON SURGICAL SUTURES

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension TPSA Flex reagent cartridge (RF451)

Suture, Nonabsorbable, Synthetic, Polypropylene

FDA Pre-Market Approval

FDA Class 2 ·POLYPROPYLENE SURGICAL SUTURE

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BOIL N SOAK CONTACT LENS FLUID

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS EGFR MUTATION TEST

Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

FDA Pre-Market Approval

FDA Class 2 ·NEODYMIUM-YAG OP LASER OPL-3

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BOIL N SOAK CONTACT LENS FLUID