- Gemini is registered with the FDA as a Class 1 Medical Device manufacturer
- Gemini manufacture the VTM under QSR and in compliance with 21CFR820 as well as aligning with 21 CFR part 210 and 211 for our pharmaceutical customers.
- Originates from the CDC formulation SOP# DSR-052-03.
- We use gamma irradiated tubes that are DNAse and RNAse free
- FBS that is used in the formulation is gamma irradiated using 25 – 40 KGy
- The sourcing of the FBS is from a country of negligible risk for BSE/ TSE as determined by the OIE
- Gemini prepares the intermediates for the VTM (Gentamycin, amphotericin B and HBSS) using USP and/ or ACS grade raw materials when possible
- Intermediates are also manufactured under QSR and in compliance with 21 CFR 820.
- All tube filling is performed in an ISO 5 environment with environmental monitoring
- The VTM is filtered through a 0.2 μm filter prior to filling tubes and a filter integrity test is performed to ensure the filter was operating correctly.
Ships on blue ice. Store at 4-8°C.
Please note: This is not a kit and does not contain a swab.