FDA.reportPublic FDA data

Revvity Health Sciences, Inc.

Matched from indexed company URL: Revvity, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12246091000513616Revvity Health Sciences, Inc.1Y2026-01-01549 ALBANY ST. BOSTON MA US 02118
30040498043004049804Revvity Singapore Pte Ltd1N2026-01-01438A Alexandra Road, 02-05/10 Alexandra Technopark Singapore Central Singapore SG 119967
30071450153007145015Revvity Health Sciences, Inc.1N2026-01-0117 P&N Drive Greenville SC US 29611
30099814843009981484Revvity Health Sciences, Inc.1N2026-01-0168 Elm St Hopkinton MA US 01748
30323244013032324401Revvity Discovery Limited1N2026-01-01Building 8100 Cambridge Research Park Cambrige Cambridgeshire GB CB25 9TL

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1278571154543389K121864PERKINELMER 226 SAMPLE COLLECTION DEVICESPJC2013-03-12
1596661269378265
1277921626128506
1596661925114460
1278571000547569
1277921054814240
1278571331321886
3404691612781967
1596661736385580

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PJC12013-03-12

GUDID#

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™ 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™ 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 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™ 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™ 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