ACCESS R-CLONE ANA PROFILE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

VARELISA RECOMBI ANA PROFILE, MODEL 18496

FDA 510(k)

FDA Class 2 ·Immunology

ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT

FDA 510(k)

FDA Class 2 ·Immunology

KALLESTAD FLORESCENT ANA/AMA/ASMA TEST

FDA 510(k)

FDA Class 2 ·Immunology

K/K (ASMA/ANA) UNIVERSAL BIOPAK

FDA 510(k)

FDA Class 2 ·Immunology

THERATEST EL-ANA PROFILES TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·BRACANALYSIS CDX DEVICE

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Powerheart® G5 AED

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Powerheart® G5 AED

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·PATH VYSION HER-2 DNA PROBE KIT

Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

FDA Pre-Market Approval

FDA Class 3 ·URO VYSION BLADDER CANCER KIT

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

Injection Kit

FDA registration

PICOCYL·2 products·🇺🇸 United States

Monocryl Un-dyed

FDA registration

PRONORTH MEDICAL·2 products·🇨🇦 Canada

Apellis Injection Kit

FDA registration

PICOCYL·2 products·🇺🇸 United States

Suture, Absorbable, Synthetic, Polyglycolic Acid - Suture, Absorbable, Synthetic - DeRoyal

FDA registration

DeRoyal Industries, Inc.·2 products·🇺🇸 United States

MONOCRYL (Dyed) Suture

FDA registration

ETHICON, INC.·2 products·🇲🇽 Mexico

Injection Kit

FDA registration

ALTAVIZ, LLC·2 products·🇺🇸 United States