Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1036832

FEI Number

1036832

Entity Name

THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC

City/State/Country

ASHEVILLE, NC, US

Establishment Address

275 Aiken Rd, ASHEVILLE, NC 28804, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

THERMO FISHER SCIENTIFIC INC. (Owner Number: 2182773)

Owner / Operator Contact Address

168 Third Avenue, --, Waltham, MA 02451, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Thermo Scientific TSX Core Series Ultra-Low Temperature Freezer TSX70086MA Thermo Scientific TSX Core Series Ultra-Low Temperature Freezer TSX40086MA Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC25286LV Thermo Scientific Plasma Freezer TSX2330LV, TSX2330LY, TSX2330LZ Fisherbrand Isotemp Ultra-Low-Temperature Freezers IUE50086LA, IUE50086LD, IUE50086LV Thermo Scientific CryoMed TSCM48MA (CryoMed MD 48L w/o print 120v) Thermo Scientific CryoMed TSCM34EL (CryoMed MD 34L w/ print 100v) Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC39686LD HERAfreeze HDE Series -40 C Ultra-Low Temperature Freezers HDE40040LA, HDE40040LD,HDE40040LV Thermo Scientific CryoMed TSCM17TA (CRF CTS MD 17L w/print 120V) Thermo Scientific HERAFreeze Freezers HDE60086LA Thermo Scientific Forma Blood Bank Refrigerator FRBB3004A, FRBB3004D, FRBB3004V, FRBB3004W Thermo Scientific Blood Bank Refrigerators TSX1204BA, TSX1204BD, TSX1204BV Thermo Scientific CryoMed TSCM48EA (CryoMed MD 48L w/ print 120v) Thermo Scientific TSX Series High-Performance Plasma Freezer TSX2330LA, TSX2330LD Thermo Scientific CryoMed TSCM48MV (CryoMed MD 48L w/o print 230v) Thermo Scientific TSX Series High-Performance Plasma Freezer TSX3030LA, TSX3030LD Thermo Scientific Revco Freezers RDE50086LA, RDE50086LD, RDE50086LV, RDE60086LA, RDE60086LD, RDE60086LV Thermo Scientific TDE Series -40 C Ultra-Low Temperature Freezers TDE60040LA, TDE60040LD, TDE60040LV Thermo Scientific Forma Freezers FDE50086LA, FDE50086LD, FDE50086LV, FDE60086LA, FDE60086LD, FDE60086LV Thermo Scientific Revco Blood Bank Refrigerator REB5004A, REB5004D, REB5004V, REB5004W VWR Series Chest Ultra-Low Temperature Freezer VWRC25286LA Thermo Scientific CryoMed TSCM34MV (CryoMed MD 34L w/o print 230v) Thermo Scientific TSX Series High-Performance Plasma Freezer TSX1230LA, TSX1230LD Thermo Scientific Revco Freezers RDE30086LA, RDE30086LD, RDE30086LV, RDE40086LA, RDE40086LD, RDE40086LV Thermo Scientific Revco RDE Series -40 C Ultra-Low Temperature Freezers RDE60040LA, RDE60040LD, RDE60040LV Thermo Scientific CryoMed TSCM17EV (CryoMed MD 17L w/ print 230v) Thermo Scientific HERAFreeze Freezers HDE50086LD, HDE50086LV, HDE60086LD, HDE60086LV Thermo Scientific Revco Blood Bank Refrigerator REB2304A, REB2304D, REB2304V, REB2304W Thermo Scientific CryoMed TSCM48TA (CRF CTS MD 48L w/print 120V) Ultra-Low Temperature Freezer TDEC06386LV Thermo Scientific TSX Series High-Performance Blood Bank Refrigerator TSX2304BA, TSX2304BD, TSX2304BV Thermo Scientific Forma FDE Series -40 C Ultra-Low Temperature Freezers FDE40040LA, FDE40040LD, FDE40040LV Fisherbrand Isotemp Ultra-Low-Temperature Freezers IUE60086LA, IUE60086LD, IUE60086LV Thermo Scientific HERAFreeze Freezers HDE50086LA Thermo Scientific Forma Blood Bank Refrigerator FRBB1204A, FRBB1204D, FRBB1204V, FRBB1204W Thermo Scientific Revco RDE Series -40 C Ultra-Low Temperature Freezers RDE40040LA, RDE40040LD, RDE40040LV Thermo Scientific CryoMed TSCM34CA (CRF CTS MD 34L w/o print 120V) Ultra-Low Temperature Freezer TDEC25286LV Thermo Scientific Jewett Blood Bank Refrigerator JBB5004A, JBB5004D, JBB5004V, JBB5004W VWR Series Chest Ultra-Low Temperature Freezer VWRC25286LD Thermo Scientific Blood Bank Refrigerators TSX2304BY, TSX2304BZ Thermo Scientific Freezers TDE50086LA, TDE50086LD, TDE50086LV, TDE60086LA, TDE60086LD, TDE60086LV Thermo Scientific CryoMed TSCM34EA (CryoMed MD 34L w/ print 120v) Ultra-Low Temperature Freezer TDEC25286LA Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC06386LA Thermo Scientific Revco Ultra Low Temperature Freezer RDE60086MA, RDE60086MD, RDE60086MV Ultra-Low Temperature Freezer TDEC39686LD Thermo Scientific Revco Blood Bank Refrigerator REB404D, REB404V, REB404W Thermo Scientific CryoMed TSCM34TA (CRF CTS MD 34L w/print 120V) Ultra-Low Temperature Freezer TDEC39686LA Thermo Scientific Jewett Blood Bank Refrigerator BBR25D-2A Thermo Scientific Plasma Freezer TSX5030LV, TSX5030LY, TSX5030LZ Thermo Scientific Plasma Freezer TSX3030LV, TSX3030LY, TSX3030LZ Thermo Scientific Forma Freezers FDE30086LA, FDE30086LD, FDE30086LV, FDE40086LA, FDE40086LD, FDE40086LV Thermo Scientific Forma Blood Bank Refrigerator FRBB2304A, FRBB2304D, FRBB2304V, FRBB2304W Thermo Scientific Forma Ultra Low Temperature Freezer FDE60086MA, FDE60086MD, FDE60086MV Ultra-Low Temperature Freezer TDEC39686LV Thermo Scientific Blood Bank Refrigerators TSX3004BY, TSX3004BZ Thermo Scientific Jewett Blood Bank Refrigerator JBB1204A, JBB1204D, JBB1204V, JBB1204W Thermo Scientific Blood Bank Refrigerators TSX1204BY, TSX1204BZ Thermo Scientific Freezers TDE30086LA, TDE30086LD, TDE30086LV, TDE40086LA, TDE40086LD, TDE40086LV Thermo Scientific TSX Universal Series ULT Freezer TSX40086LA Thermo Scientific CryoMed TSCM17MV (CryoMed MD 17L w/o print 230v) Thermo Scientific TSX Series High-Performance Plasma Freezer TSX5030LA, TSX5030LD Thermo Scientific Forma FDE Series -40 C Ultra-Low Temperature Freezers FDE50040LA, FDE50040LD, FDE50040LV Thermo Scientific CryoMed TSCM34EV (CryoMed MD 34L w/ print 230v) Thermo Scientific TSX Series High-Performance Blood Bank Refrigerator TSX5004BA, TSX5004BD, TSX5004BV Thermo Scientific TSX Universal Series ULT Freezer TSX50086LA Thermo Scientific HERAfreeze Ultra Low Temperature Freezer HDE60086MA, HDE60086MD, HDE60086MV Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC25286LA Thermo Scientific Blood Bank Refrigerators TSX5004BY, TSX5004BZ Thermo Scientific CryoMed TSCM17EA (CryoMed MD 17L w/ print 120v) Thermo Scientific CryoMed TSCM48EL (CryoMed MD 48L w/ print 100v) Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC39686LV Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC25286LD Thermo Scientific Plasma Freezer TSX1230LV, TSX1230LY, TSX1230LZ Thermo Scientific CryoMed TSCM17CA (CRF CTS MD 17L w/o print 120V) Ultra-Low Temperature Freezer TDEC06386LA Thermo Scientific Plasma Blast Freezer XBF40D-MD Fisherbrand Isotemp Ultra-Low-Temperature Freezers IUE40086LA, IUE40086LD, IUE40086LV Thermo Scientific CryoMed TSCM34MA (CryoMed MD 34L w/o print 120v) Thermo Scientific CryoMed TSCM17EL (CryoMed MD 17L w/ print 100v) Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC39686LA Thermo Scientific Jewett Blood Bank Refrigerator BBR55D-2A Thermo Scientific TDE Series -40 C Ultra-Low Temperature Freezers TDE40040LA, TDE40040LD, TDE40040LV Thermo Scientific Ultra Low Temperature Freezer TDE60086MA,TDE60086MD, TDE60086MV Thermo Scientific CryoMed TSCM34ML (CryoMed MD 34L w/o print 100v) Thermo Scientific Forma Blood Bank Refrigerator FRBB404A, FRBB404V, FRBB404W VWR Series Chest Ultra-Low Temperature Freezer VWRC39686LD Thermo Scientific Revco RDE Series -40 C Ultra-Low Temperature Freezers RDE50040LA, RDE50040LD, RDE50040LV Thermo Scientific CryoMed TSCM48CA (CRF CTS MD 48L w/o print 120V) Ultra-Low Temperature Freezer TDEC25286LD Thermo Scientific HERAFreeze Freezers HDE30086LA Thermo Scientific Revco Blood Bank Refrigerator REB1204D, REB1204V, REB1204W Thermo Scientific TSX Universal Series ULT Freezer TSX60086LA VWR Series Chest Ultra-Low Temperature Freezer VWRC39686LA HERAfreeze HDE Series -40 C Ultra-Low Temperature Freezers HDE50040LA, HDE50040LD,HDE50040LV Thermo Scientific CryoMed TSCM48EV (CryoMed MD 48L w/ print 230v) Thermo Scientific Jewett Blood Bank Refrigerator JBB404A, JBB404D, JBB404V, JBB404W Thermo Scientific Forma FDE Series -40 C Ultra-Low Temperature Freezers FDE60040LA, FDE60040LD, FDE60040LV Thermo Scientific CryoMed TSCM17ML (CryoMed MD 17L w/o print 100v) Thermo Scientific Forma Blood Bank Refrigerator FRBB5004A, FRBB5004D, FRBB5004V, FRBB5004W Thermo Scientific Revco Blood Bank Refrigerator REB3004A, REB3004D, REB3004V, REB3004W Thermo Scientific TSX Universal Series ULT Freezer TSX70086LA Thermo Scientific TDE Series -40 C Ultra-Low Temperature Freezers TDE50040LA, TDE50040LD, TDE50040LV Thermo Scientific HERAFreeze Freezers HDE40086LA Thermo Scientific Jewett Blood Bank Refrigerator BBR55D-1B VWR Series Chest Ultra-Low Temperature Freezer VWRC06386LA HERAfreeze HDE Series -40 C Ultra-Low Temperature Freezers HDE60040LA, HDE60040LD,HDE60040LV Thermo Scientific HERAFreeze Freezers HDE30086LD, HDE30086LV, HDE40086LD, HDE40086LV, Thermo Scientific Jewett Blood Bank Refrigerator JBB2304A, JBB2304D, JBB2304V, JBB2304W Fisherbrand Isotemp Ultra-Low-Temperature Freezers IUE30086LA, IUE30086LD, IUE30086LV Thermo Scientific CryoMed TSCM17MA (CryoMed MD 17L w/o print 120v) Thermo Scientific CryoMed TSCM48ML (CryoMed MD 48L w/o print 100v) Thermo Scientific Jewett Blood Bank Refrigerator JBB3004A, JBB3004D, JBB3004V, JBB3004W Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC06386LV Thermo Scientific Blood Bank Refrigerators TSX3004BA, TSX3004BD, TSX3004BV Thermo Scientific TSX Core Series Ultra-Low Temperature Freezer TSX60086MA Thermo Scientific TSX Core Series Ultra-Low Temperature Freezer TSX50086MA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KSE	Refrigerator, Freezer, Blood Storage	Hematology	Class 2	864.9700	1992-11-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

THERMO FISHER SCIENTIFIC INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003809634	Thermo Finnigan LLC	San Jose, CA, US
9610942	THERMO FISHER SCIENTIFIC OY	VANTAA Uusimaa, FI
8010672	THERMO ELECTRON LED GmbH	OSTERODE Lower Saxony, DE
1523845	THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC	MARIETTA, OH, US
9617472	THERMO ELECTRON LED GmbH	Langenselbold Hesse, DE

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1036832. Last updated year: 2026. Please use registration number 1036832 when referencing this establishment in official correspondence.