Who supplies the components of the MyOme collection kits
- Buccal swab kits: DNAGenotek (OCD-100)
- Biohazard bags, absorbent pads, packaging materials: Standard laboratory-grade suppliers through our fulfillment partner GBF
- Labels, IFUs, shipping materials: MyOme, fulfilled and assembled through our logistics provider GBF
The kit is not FDA-listed as a medical device. It is classified as a general specimen collection kit, Class I exempt, and does not carry diagnostic or analytical claims itself. It is used solely for DNA sample collection for testing within MyOme’s CLIA-certified laboratory.