FDA.reportPublic FDA data

BLUE LIFE SOLUTIONS, LLC.

Matched from indexed company URL: Blue Life Solutions, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30272660363027266036BLUE LIFE SOLUTIONS, LLC.1N2026-01-012015 E Helm Ave. Las Vegas NV US 89119

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3159471198143809K231013DNA/RNA Shield SafeCollect Saliva Collection kitQBD2023-09-28
3159471231369083K202641DNA/RNA Shield Collection TubeQBD2020-12-14
3159472061515693

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QBD22023-09-28

GUDID#

DNA/RNA Shield™ SafeCollect Saliva Collection Kit - The DNA/RNA Shield™ SafeCollect Saliva Collection Kit is intended for the collection, inactivation, stabilization, and transportation, of unprocessed saliva specimens suspected of containing SARS-CoV-2. The DNA/RNA Shield™ SafeCollect Saliva Collection Kit is intended to transport and store saliva specimens at ambient temperature (20-25°C) from the collection site to the laboratory. Specimens collected and preserved in a DNA/RNA Shield™ SafeCollect Saliva Collection kit sample collection tube are suitable for use with legally marketed molecular diagnostic devices.

Blue Life Solutions, LLC

2024-01-01