Revvity Limited

Matched from indexed company URL: Revvity, Inc.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
		Revvity Limited	5	N	2026-01-01	Llantrisant Business Park Llantrisant Pontyclun Wales GB CF72 8YW
1224609	1000513616	Revvity Health Sciences, Inc.	1	Y	2026-01-01	549 ALBANY ST. BOSTON MA US 02118
3004049804	3004049804	Revvity Singapore Pte Ltd	1	N	2026-01-01	438A Alexandra Road, 02-05/10 Alexandra Technopark Singapore Central Singapore SG 119967
3007145015	3007145015	Revvity Health Sciences, Inc.	1	N	2026-01-01	17 P&N Drive Greenville SC US 29611
3009981484	3009981484	Revvity Health Sciences, Inc.	1	Y	2026-01-01	68 Elm St Hopkinton MA US 01748
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, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
127857	1154543389	K121864	PERKINELMER 226 SAMPLE COLLECTION DEVICES	PJC	2013-03-12
159666	1269378265
127792	1626128506
159666	1925114460
127857	1000547569
127792	1054814240
351700	1054814240
127857	1331321886
340469	1612781967
159666	1736385580

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
PJC	1	2013-03-12

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™ 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
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
PerkinElmer GRNK1 Card - Dried Blood Spot Collection Card
Revvity, Inc.
2022-09-23
PerkinElmer GRNK1 Card - Dried Blood Spot Collection Card
Revvity, Inc.
2022-09-23
Revvity 226 - Newborn Screening Card
Revvity, Inc.
2016-08-29
Revvity 226 - Newborn Screening Card
Revvity, Inc.
2016-08-29
Revvity 226 - Newborn Screening Card
Revvity, Inc.
2016-08-29
Revvity 226 - Newborn Screening Card
Revvity, Inc.
2016-08-29
Revvity 226 - Newborn Screening Card
Revvity, Inc.
2016-08-29
Revvity GRNK1 Card - Dried Blood Spot Collection Card
Revvity, Inc.
2023-08-17
Revvity GRNK1 Card - Dried Blood Spot Collection Card
Revvity, Inc.
2023-08-17
PinAAcle900 Atomic Absorption Spectrometer - For use in clinical applications; identification is according to the wavelength and intensity of the light that is absorbed when the specimen is converted to the atomic vapor phase.
REVVITY SINGAPORE PTE. LTD.
2020-05-14
PinAAcle900 Atomic Absorption Spectrometer - For use in clinical applications; identification is according to the wavelength and intensity of the light that is absorbed when the specimen is converted to the atomic vapor phase.
REVVITY SINGAPORE PTE. LTD.
2020-05-14
PinAAcle900 Atomic Absorption Spectrometer - For use in clinical applications; identification is according to the wavelength and intensity of the light that is absorbed when the specimen is converted to the atomic vapor phase.
REVVITY SINGAPORE PTE. LTD.
2020-05-14
WIZARD² Gamma Counter - An automated gamma counter to detect and count gamma radiation emitted by clinical samples that were prepared through the addition of a radioactive reagent.
REVVITY SINGAPORE PTE. LTD.
2020-05-14
WIZARD² Gamma Counter - An automated gamma counter to detect and count gamma radiation emitted by clinical samples that were prepared through the addition of a radioactive reagent.
REVVITY SINGAPORE PTE. LTD.
2020-05-14
WIZARD² Gamma Counter - An automated gamma counter to detect and count gamma radiation emitted by clinical samples that were prepared through the addition of a radioactive reagent.
REVVITY SINGAPORE PTE. LTD.
2020-05-14
WIZARD² Gamma Counter - An automated gamma counter to detect and count gamma radiation emitted by clinical samples that were prepared through the addition of a radioactive reagent.
REVVITY SINGAPORE PTE. LTD.
2020-05-14
WIZARD² Gamma Counter - An automated gamma counter to detect and count gamma radiation emitted by clinical samples that were prepared through the addition of a radioactive reagent.
REVVITY SINGAPORE PTE. LTD.
2020-05-14
WIZARD² Gamma Counter - An automated gamma counter to detect and count gamma radiation emitted by clinical samples that were prepared through the addition of a radioactive reagent.
REVVITY SINGAPORE PTE. LTD.
2020-05-14
WIZARD² Gamma Counter - An automated gamma counter to detect and count gamma radiation emitted by clinical samples that were prepared through the addition of a radioactive reagent.
REVVITY SINGAPORE PTE. LTD.
2020-05-14
WIZARD² Gamma Counter - An automated gamma counter to detect and count gamma radiation emitted by clinical samples that were prepared through the addition of a radioactive reagent.
REVVITY SINGAPORE PTE. LTD.
2020-05-14
WIZARD² Gamma Counter - An automated gamma counter to detect and count gamma radiation emitted by clinical samples that were prepared through the addition of a radioactive reagent.
REVVITY SINGAPORE PTE. LTD.
2020-05-14
WIZARD² Gamma Counter - An automated gamma counter to detect and count gamma radiation emitted by clinical samples that were prepared through the addition of a radioactive reagent.
REVVITY SINGAPORE PTE. LTD.
2020-05-14
WIZARD² Gamma Counter - An automated gamma counter to detect and count gamma radiation emitted by clinical samples that were prepared through the addition of a radioactive reagent.
REVVITY SINGAPORE PTE. LTD.
2020-05-14