Data / Medical devices / United States / Blue Life Solutions, LLC.
Blue Life Solutions, LLC.: FDA-registered device maker in Las Vegas, NV, United States, 2 510(k) clearances
Blue Life Solutions, LLC. is registered with the FDA (registration 3027266036) in Las Vegas, NV, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 28, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027266036
- Address
- 2015 E Helm Ave., Las Vegas, NV, United States, 89119
- Owner or operator
- Blue Life Solutions, LLC. (10087684)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- April 6, 2023
- Registered through
- 2026
- Brand names listed
- Bunny Wipe, DNA/RNA Shield Collection Tube w/ Swab, DNA/RNA Shield SafeCollect Saliva Collection Kit, DNA/RNA Shield collection tube
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, Specimen, Non-Sterile | NNI | 1 | Manufacturer | accessdata.fda.gov |
| Microbial Nucleic Acid Storage And Stabilization Device | QBD | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 28, 2023 | K231013 | DNA/RNA Shield SafeCollect Saliva Collection kit | QBD | Substantially Equivalent | Zymo Research | accessdata.fda.gov |
| December 14, 2020 | K202641 | DNA/RNA Shield Collection Tube | QBD | Substantially Equivalent | Zymo Research | accessdata.fda.gov |
Compare with other makers
- All makers of Container, Specimen, Non-Sterile
- All makers of Microbial Nucleic Acid Storage And Stabilization Device
Updated September 28, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.