Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004003025

FEI Number

3004003025

Entity Name

COVARIS, LLC

City/State/Country

Woburn, MA, US

Establishment Address

14 Gill St, Unit H, Woburn, MA 01801, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Covaris, LLC (Owner Number: 10083257)

Owner / Operator Contact Address

14 Gill St, Unit H, Woburn, MA 01801, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

M220 Focused-ultrasonicator Chiller CH05 ML230 Focused-ultrasonicator R230 Focused-ultrasonicator LE220-plus Focused-ultrasonicator truCOLLECT® Whole Blood Collection Kit (100) truCOLLECT Convenience Kit (10) truCOLLECT® Collection Device (10) truCOLLECT® Whole Blood Collection Kit (10) Whole Blood Collection Kit (10), truCOLLECT truCOLLECT Convenience Kit truCOLLECT Whole Blood Collection Kit truCOLLECT® Collection Device (100) truXTRAC FFPE total NA Plus 384 Kit - Magnetic Bead truCOVER WGS PCR free DNA Library Prep Kit truXTRAC FFPE total NA Ultra Kit - Magnetic Bead truXTRAC FFPE DNA microTUBE Kit - Column Purification (25) truXTRAC FFPE tNA Auto 96 Kit CO1 truXTRAC FFPE RNA microTUBE Kit -Column Purification (25) truChIP Chromatin Shearing Kit with Formaldehyde truXTRAC FFPE total NA Plus Kit - Column truCOVER Library Amplification Kit truPREP Protein Isolation, Purification (Manual) truPREP Protein Isolation, Purification, Digestion (Manual) truPREP Protein 12x8 Strip Kit FFPE Manual truXTRAC FFPE total NA Kit Plus Kit - Magnetic Bead truXTRAC FFPE Total NA Auto 96 Kit truCOLLECT DNA Extraction kit (96) truXTRAC FFPE DNA Plus Kit - Magnetic Bead truXTRAC FFPE tNA Auto 96 Kit CO2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2026-03-06
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2026-03-06
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2026-03-06

Official Correspondent

ARGENIS GONZALEZ

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Covaris, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

Similar Registrations

Registration Number	Establishment Name	Location
3003027964	Flex Precision Plastics Solutions (Switzerland) AG	Hagglingen Aargau, CH
3009965750	IMS ENGINEERED PRODUCTS, LLC	Des Plaines, IL, US
3008937875	Nissha FIS, Inc.	Osaka, JP
3004488394	TIGER MEDICAL GROUP	SHANGHAI, CN
3003542872	NPA de México S. de R.L. de C.V.	TIJUANA Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004003025. Last updated year: 2026. Please use registration number 3004003025 when referencing this establishment in official correspondence.