Help improve testing efficiency and reliability with our USDA-licensed diagnostic solutions

The USDA Animal and Plant Health Inspection Service (APHIS) regulates veterinary biologics (vaccines, bacterins, antisera, diagnostic kits, and other products of biological origin) to help ensure that the veterinary biologics available for the diagnosis, prevention, and treatment of animal diseases are safe and effective. The APHIS Center for Veterinary Biologics (CVB) carries out this work, focusing on enforcement of the Virus Serum Toxin Act.

Thermo Fisher Scientific animal health products have been at the forefront of recent advances in production animal diagnostics, and are some of the leading modern diagnostic tools to veterinary laboratories around the world.

In keeping with our commitment to deliver the highest-quality next-generation molecular tools, we provide several farm animal diagnostic solutions that have been validated through the stringent USDA licensure process. This includes innovative USDA-licensed detection kits that offer rapid, easy-to-use PCR-based testing solutions that are designed to detect bovine viral diarrhea virus (BVDV), swine influenza virus (SIV), and avian influenza virus (AIV) with exceptional specificity, sensitivity, and reproducibility.

Demystifying USDA licensure

Thermo Fisher Scientific hosted an event attended by state veterinarians that included a presentation explaining the USDA licensure process, as well as the production and performance criteria that veterinary diagnostic test kits must satisfy to earn a USDA license. See below to view the presentation video.

Mary Anne Williams
Senior Manager, Regulatory Affairs
Thermo Fisher Scientific

Free webinar

Register for “Demystifying USDA licensure and its importance to diagnostics testing”. Please click the "Register" button below to attend this free on demand webinar and learn about the process to obtain a USDA license, the importance of using USDA-licensed kits, and the benefits to laboratories, veterinarians, and health officials.

Register for webinar

VetMAX-Gold USDA-licensed solutions

Applied Biosystems™ VetMAX™-Gold MAP Detection Kit—A USDA-licensed real-time PCR test for the detection of Mycobacterium avium subsp. paratuberculosis (MAP) in beef and dairy cattle.
  • Validated for use with single cattle feces samples or pooled samples of up to 5 animals
  • Demonstrated high sensitivity (96.2%) and specificity (96.4–100%) in USDA validation study
  • Proven repeatability (100%) and reproducibility (100%) in USDA validation study
  • Simple workflow tailored for MAP detection that is easily automated for high-throughput processing
  • Includes Applied Biosystems™ VetMAX™ Xeno™ Internal Positive Control to help prevent false signals from nonspecific targets
  • Routine monitoring of our manufacturing site for compliance with production and quality system guidelines

Find out more ›           Download product flyer ›

Applied Biosystems™ VetMAX™-Gold SIV Solutions—A USDA-licensed, real-time PCR screening and subtyping kits for the rapid detection of swine influenza virus (SIV)
  • SIV Detection Kit sensitivity of 98.4% and specificity of 99.1%
  • SIV Subtyping Detection Kit sensitivity of 98.2% and specificity of 100%
  • Real-time PCR technology helps improve reproducibility via assay standardization
  • Genomic targeting helps reduce risk of false negatives caused by genomic mutation
  • Kits are designed to provide rapid detection of SIV RNA extracted from porcine nasal swabs
  • USDA authorized representatives oversee the quality control process and the release of every batch

Find out more ›    Download product flyer ›

Applied Biosystems™ VetMAX™-Gold AIV Detection Kit—A rapid PCR-based testing solution that detects avian influenza with high specificity, sensitivity, and reproducibility.
  • Designed to screen 3 genomic regions to detect AIV with exceptional sensitivity and specificity
  • A simplified, validated workflow helps labs streamline their testing process
  • Real-time PCR technology enables greater testing consistency and reproducibility
  • USDA oversees the quality control process and the release of every batch

Find out more ›  Download product flyer ›


For Veterinary Use Only. For In Vitro Use Only. Regulatory requirements vary by country; products may not be available in your geographic area.