Revvity Discovery Limited

Matched from indexed company URL: REVVITY DISCOVERY LIMITED

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3032324401	3032324401	Revvity Discovery Limited	1	N	2026-01-01	Building 8100 Cambridge Research Park Cambrige Cambridgeshire GB CB25 9TL

Registered Device Listings#

Registration key, Listing key table
Registration key	Listing key
340469	1612781967

GUDID#

Mimix™ Geni™ OncoMix 1 DNA/RNA FFPE Reference Standard - The Mimix™ Geni™ OncoMix 1 DNA/RNA FFPE Reference Standard is a commutable control material comprising a formalin-fixed paraffin-embedded (FFPE) curl made from a multiplex of 7 engineered cell lines from the GM24385 Genome in a Bottle Consortium Cell line (GIAB), containing 5 single nucleotide polymorphisms (SNPs) and 2 gene fusions. It is intended for quantitative and/or qualitative monitoring of next-generation sequencing (NGS) or droplet digital polymerase chain reaction (ddPCR) assays designed to detect somatic mutations and gene fusions in genomic DNA (gDNA) or RNA from human samples for in vitro diagnostic use. The gDNA or RNA obtained from Geni OncoMix 1 DNA/RNA FFPE Reference Standard can be used to monitor NGS or ddPCR workflows, test performance, assay variation and helps identify increases in random or systematic errors. This product is for professional laboratory use only.
REVVITY DISCOVERY LIMITED
2026-03-27
Mimix™ Geni™ Negative FFPE Reference Standard - The Mimix™ Geni™ Negative FFPE Reference Standard is a commutable control material comprising a formalin-fixed paraffin-embedded (FFPE) curl derived from the GM24385 Genome-in-a-Bottle Consortium (GIAB) cell line, with no additional genomic interventions. It is intended for qualitative and/or quantitative monitoring of next generation sequencing (NGS) and droplet digital polymerase chain reaction (ddPCR) assays designed to detect somatic oncogenic mutations and gene fusions in genomic DNA (gDNA) or RNA from human samples for in vitro diagnostic use. The gDNA or RNA obtained from Mimix Geni Negative FFPE Reference Standard can be used to monitor NGS or ddPCR workflows, test performance, assay variation and helps identify increases in random or systematic errors. This product is for professional laboratory use only.
REVVITY DISCOVERY LIMITED
2026-03-27
Mimix™ Quantitative Multiplex FFPE reference standard - The Mimix™ Quantitative Multiplex FFPE Reference Standard is a commutable control material comprising a formalin-fixed paraffin-embedded (FFPE) curl derived from human cancer cell lines. It is intended for quantitative and/or qualitative monitoring using droplet digital polymerase chain reaction (ddPCR) assays designed to detect somatic mutations in genomic DNA (gDNA) from human samples for in vitro diagnostic use. The gDNA obtained from Quantitative Multiplex FFPE Reference Standard can be used to monitor ddPCR workflow, test performance, assay variation and helps identify increases in random or systematic errors. This product is for professional laboratory use only.
REVVITY DISCOVERY LIMITED
2025-08-15
Mimix™ OncoSpan FFPE Reference Standard - The Mimix™ OncoSpan FFPE reference standard is a commutable control material comprising a formalin-fixed paraffin-embedded (FFPE) curl derived from human cancer cell lines, containing more than 380 variants across 152 cancer genes. It is intended for qualitative and/or quantitative monitoring of next-generation sequencing (NGS) or droplet digital polymerase chain reaction (ddPCR) assays designed to detect somatic mutations in genomic DNA (gDNA) from human samples for in vitro diagnostic use. The gDNA obtained from OncoSpan FFPE Reference Standard can be used in NGS or ddPCR workflow, test performance, assay variation and helps identify increases in random or systematic errors. This product is for professional laboratory use only.
REVVITY DISCOVERY LIMITED
2025-06-05
Mimix™ OncoSpan gDNA Reference Standard - The Mimix™ OncoSpan gDNA reference standard is a commutable control material comprising a mixture of genomic DNA (gDNA) derived from human cancer cell lines, containing more than 380 variants across 152 cancer genes. It is intended for qualitative and/or quantitative monitoring of next-generation sequencing (NGS) and droplet digital polymerase chain reaction (ddPCR) assays designed to detect somatic mutations in human gDNA samples for in vitro diagnostic use. This control can be used to monitor NGS and ddPCR workflow, test performance, assay variation and helps identify increases in random or systematic errors. This product is for professional laboratory use only.
REVVITY DISCOVERY LIMITED
2025-06-05
Mimix™ Myeloid Cancer Panel gDNA Reference Standard - The Mimix™ Myeloid Cancer Panel gDNA reference standard is a cell line derived control material that contains 22 variants across 19 genes relevant to myeloid cancer. It is intended for qualitative and/or quantitative monitoring of next-generation sequencing (NGS) and droplet digital polymerase chain reaction (ddPCR) assays designed to detect somatic mutations in human gDNA samples for in vitro diagnostic use. This control can be used to monitor NGS and ddPCR workflow, test performance, assay variation and helps identify increases in random or systematic errors. This product is for professional laboratory use only.
REVVITY DISCOVERY LIMITED
2025-06-05