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ADT Biotech launches LyteStar HCV Genotyping Kit

04/2019 – ADT Biotech’s recently launched LyteStarTM HCV Genotyping Kit is a ready-to-use real-time PCR kit for the detection and identification of HCV Genotypes 1 – 6, and further typing of Subtypes 1a and 1b. In addition to the genotype specific assays, the kit contains an amplification system for all HCV genotypes (HCV consensus) and an Internal Control to monitor extraction efficiency, potential PCR inhibition and the integrity of all kit components.

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GeneProof HBV and HCV kits obtain CDSCO approval in India

03/2019 – GeneProofs kits for detection and viral load determination of Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) are now available in India.  Both products have been granted an import license by the Central Drugs Standard Control Organization (CDSCO) in March 2019.

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GeneProof kits obtain import license in Thailand

01/2019 – GeneProofs complete product range of CE IVD certified products has been granted market authorization in Thailand by registration under Thai FDA.

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LyteStar TB/NTM kit now registered in Thailand

07/2018 – ADT’s LyteStar TB/NTM kit has achieved market authorization in Thailand by registration under Thai FDA.

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PathoNostics kit obtains market approval in Malaysia

06/2018 – PathoNostics AsperGenius kit has achieved market authorization in Malaysia with registration by the Medical Device Authority (MDA) .

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PathoFinder kits now registered in Malaysia

06/2018 – PathoFinders RespiFinder, MeningoFinder and STD-Finder kits have been registered with the Medical Device Authority (MDA) in Malaysia.

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PathoFinder kits achieve registration in Thailand

02/2018 – PathoFinders RespiFinder, MeningoFinder and STD-Finder kits have achieved regulatory approval by Thai FDA in Thailand.

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GeneProof HIV kit now registered in Malaysia

02/2018 – GeneProof HIV kit has achieved market authorization in Malaysia with registration by the Medical Device Authority (MDA) .

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GeneProof HBV and HCV kits obtain market authorization in Malaysia

12/2017 – GeneProof HBV and HCV kits have achieved product registration with Medical Device Authority (MDA) in Malaysia.

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PathoNostics kits now registered in India

12/2017 – PathoNostics AsperGenius, PneumoGenius and DermaGenius kits achieve market authorization in India under the Central Drugs Standard Control Organization (CDCSO).

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PathoFinder kits achieve registration in India

12/2017 – PathoFinders RealAccurate Quadruplex Corona and RSV/hMPV kits achieve market authorization in India under the Central Drugs Standard Control Organization (CDCSO).

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GeneProof kits achieve import license in India

11/2017 – GeneProof non-notified in vitro diagnostic kits achieve Import License in India under the Central Drugs Standard Control Organization (CDCSO).

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PathoNostics kits achieve registration in Australia

11/2017 – PathoNostics AsperGenius and DermaGenius kits have achieved registration in the Australian Register of Therapeutic Goods (ARTG).

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