FDA.reportPublic FDA data

HemoTemp II Activator

Primary DI
00815236020926
Brand
HemoTemp II Activator
Company
LCR HALLCREST, LLC.
Model
9000
Published
2022-06-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JRGBlock, Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JRGBlock, HeatingClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815236020923PackageGS11In Commercial Distribution
M74490000PreviousHIBCC0
00815236020926PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081523602092310815236020923
00815236020926008152360209268152360209260815236020926

GMDN Terms#

Term, Definition table
TermDefinition
Heating block IVDAn electrically-powered device which is primarily a heating element, with or without a thermostat, that is built into a compact block and intended to be used as a stable dry heat source to heat in vitro diagnostic specimens/laboratory materials. It is typically a stand-alone instrument, or an interchangeable component of an in vitro diagnostic instrument/analyser. It is available in various sizes to accommodate microplates of varying sizes, and may include covers to minimize evaporation from microplates.

Contacts#

Phone, Email table
PhoneEmail
847-998-8580orders@hallcrest.com

Regulatory Flags#

DUNS number
059247507
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10815236020671FeverScanBB150BB1502016-09-24
10815236020695FeverScanBB150BB1502016-09-24
10815236021050HemoTemp20002022-06-20
10815236021074TempTrend II11002022-06-20
10815236021104StaFreez50002022-06-20
10815236021135LabTemp 4061002022-06-20
20815236021057HemoTemp20002022-06-20
20815236021071TempTrend II11002022-06-20
20815236021101StaFreez50002022-06-20
20815236021132LabTemp 4061002022-06-20
10815236021128LabTemp 2060002022-06-16
10815236020923HemoTemp II Activator90002022-06-16
20815236021125LabTemp 2060002022-06-16
10815236020176Crystaline® Moving Line5101C-MLC5101C-MLC2022-03-01
10815236020183Crystaline® Moving Line5101H-MLC5101H-MLC2022-03-01
10815236020190Crystaline® Moving Line5101SD-MLC5101SD-MLC2022-03-01
10815236020206Crystaline® Moving Line5101SB-MLC5101SB-MLC2022-03-01
20815236020173Crystaline® Moving Line5101C-MLC5101C-MLC2022-03-01
20815236020180Crystaline® Moving Line5101H-MLC5101H-MLC2022-03-01
20815236020197Crystaline® Moving Line5101SD-MLC5101SD-MLC2022-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06973843220901ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
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06973843221120Thermo CellHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221137Thermo CellHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
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10815236020923HemoTemp II ActivatorLCR HALLCREST, LLC.JRG2022-06-16