reditest®

FDA UDI

REDWOOD TOXICOLOGY LABORATORY, INC.·10858904006140·PANEL 2 COC/OPI

UCP Home Drug Screening Test Cards

FDA UDI

UCP BIOSCIENCES, INC.·10817038021474·UCP Home Drug Screening Test Cards 12 Panel Dru...

iScreen™

FDA UDI

Instant Technologies, Inc.·00817405021994·iScreen DOA Multi-Panel(Urine) 25T

iScreen™

FDA UDI

Instant Technologies, Inc.·00817405022373·iScreen DOA Multi-Panel(Urine) 25T

iScreen™

FDA UDI

Instant Technologies, Inc.·00817405022038·iScreen DOA Multi-Panel(Urine) 25T

ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FDA Pre-Market Approval

MOSAIC PORCINE BIOPROSTHESIS

ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Epidermal Growth Factor Receptor (EGFR) - 31G7 - Mob461A,PDM226A

FDA registration

DIAGNOSTIC BIOSYSTEMS·1 product·🇺🇸 United States

BROWNE TST SINGLE USE BOWIE DICK TYPE TEST PACK

FDA 510(k)

FDA Class 2 ·General Hospital

BROWNE GA INDICATOR USE IN 2% ACTIV GLUTARALDEHYDE

FDA 510(k)

FDA Class 2 ·General Hospital

TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE

FDA 510(k)

FDA Class 2 ·General Hospital

KAY-PLUS & VARIOUS VANIA SANITARY LINERS & PADS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Evidence MultiSTAT Drugs of Abuse (DOA) ToxPlex Urine Array

Device

EU IVDR · Eu Ivd Class C ·Randox Laboratories Limited·On the market·1 country

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·MEDTONIC FREESTYLE AORTIC BIOPROSTHESIS

MTG Pediatric Intermittent Catheter, Coude-tip with hydrophilic low-friction coa

FDA UDI

MEDICAL TECHNOLOGIES OF GEORGIA, INC.·00851593006302·Pediatric Intermittent Catheter, Coude-tip with...

MTG Female Intermittent Catheter, Straight-tip with hydrophilic low-friction coa

FDA UDI

MEDICAL TECHNOLOGIES OF GEORGIA, INC.·00851593006227·Female Intermittent Catheter, Straight-tip with...

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·METHAFILCON A AND METHAFILCON B SOFT HYDROPHILIC WEAR CONTACT LENSES INSTALLATION AND VALIDATION OF A NEW 3M ATTEST 290

Anti-Coa, for card method Coombs-reactive, polyclonal, human IgG

Device

EU IVDR · Eu Ivd Class C ·ANTITOXIN GmbH·On the market·2 countries

Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology