Microbial Nucleic Acid Storage And Stabilization Device

Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B

Products were distributed in the United States without FDA authorization or clearance.

RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAstill MTM specimen collection kits: MTM-SW

The product does not have 510(k) clearance.

Dasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 50, Nasal swab - 50, Package Insert - 1, IVD, CE

Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing

Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 pcs, IVD, Sterile R

Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing

Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box.

No 510(k) clearance

Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI MTM04TUBE, containing 1 tube/pack.

No 510(k) clearance

PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, LH-1-15CC - Product Usage: intended for stabilization, t

The tubes may have been delivered to some users without labels. Users may not be able to identify the tubes without these labels. If samples stored or transported in tubes are tested on certain systems or come into contact with bleach they can produce cyanide gas. The solution in these tubes contains guanidine thiocynate and may put laboratory personnel at risk of exposure to cyanide gas when it comes into contact with bleach or reagents containing bleach.