Documentation, Information & Certifications

Find the most current and available product, process, and regulatory documentation below. Don’t see what you’re looking for? Just reach out below.

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PRODUCT CHANGE NOTIFICATIONS: August 2020 | February 2021

FDA EUA Summary Unsupervised Collection

FDA EUA-200090 Summary

FDA EUA-202432 Summary (SDNA-1000)

FDA EUA-200091 Summary (At-Home)

RUDCR Proof Point: Saliva vs. Swab

Instructions For Use: SDNA-1000

SDNA-1000 Safety Data Sheet (SDS)

SDNA-2000 + 3000 Safety Data Sheet (SDS)

S+MD (SPD) Safety Data Sheet (SDS)

ISO 13485:2016 & EN ISO 13485:2016 Certificate of Registration

MDSAP 690247 Certificate of Registration

EUA FAQs COVID-19 Test Provider

EUA Patient FAQ's COVID-19 Testing

SDNA-1000 Product Data Sheet

SDNA-1000 Product Sell Sheet

S+MD Multi-Omic Collection Platform Sell Sheet

Health Canada Authorization Order

Associations, Memberships
& Credentials

MADE IN THE USA-03
HEALTH CANADA
CE MARK-02
FDA Logo
ascp_iconx125
AACC Logox250
ASCLS Logox200
AMP Logox200
ISBER Member
MDSAP
HIPPA AND HITECH MEDICAL SECURITY COMPLIANT-02
BioUtah-Logo
Utah Safety Council logo
ISO-SPECTRUM-logo-02
Current Good Manufacturing Practice
HIPAA Seal of Compliance Verified
BSI_Logo_ISO13485-images-blk

Associations, Memberships
& Credentials

HEALTH CANADA
CE MARK-02
FDA Logo
MADE IN THE USA-03
ascp_iconx125
AACC Logox250
ASCLS Logox200
AMP Logox200
ISBER Member
MDSAP
HIPPA AND HITECH MEDICAL SECURITY COMPLIANT-02
BioUtah-Logo
Utah Safety Council logo
ISO-SPECTRUM-logo-02
Current Good Manufacturing Practice
HIPAA Seal of Compliance Verified
BSI_Logo_ISO13485-images-blk

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