FDA Registration
Active
🇺🇸 United States
COVARIS, LLC
Reg #: 3004003025
·
FEI: 3004003025
·
Expires 2026
Products
4
Proprietary Names
39
Establishment Types
1
Classifications
4
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Registration Details
- Registration Name
- COVARIS, LLC
- Registration Number
- 3004003025
- FEI Number
- 3004003025
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 14 Gill St, Unit H
- City
- Woburn
- State
- MA
- ZIP
- 01801
- Country
- US
Owner / Operator
- Firm Name
- Covaris, LLC
- Operator Number
- 10083257
- Address
- 14 Gill St, Unit H
- City
- Woburn
- State
- MA
- Postal Code
- 01801
- Country
- US
- Correspondent
- ARGENIS GONZALEZ
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2026-03-06 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2026-03-06 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2026-03-06 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2026-03-06 |
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
384 AFA-TUBE 5 PP Plate (10-GSK)
96 microTUBE Plate
8 AFA-TUBE TPX Strip (12)
96 AFA-TUBE PS Plate
0.75ml Tube Consumable Kit
truCOLLECT Consumables Expansion Kit
96 microTUBE Plate (10)
96 microTUBE AFA Fiber Plate Thin Foil (10)
96 AFA-TUBE TPX Plate
Establishment Types
Manufacture Medical Device