FDA.reportPublic FDA data

HemoTemp II Activator

Primary DI
M74490000
Brand
HemoTemp II Activator
Company
BIOSYNERGY, INC.
Model
9000
Published
2017-06-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
M74490001PackageHIBCC1Not in Commercial Distribution
M74490000PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
070698154
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M74481000HemoCool Gel-Pak810081002018-01-10
M74420001HemoTemp20002016-09-01
M74450001StaFreez50002017-06-01
M74460001LabTemp 2060002017-06-01
M74420002HemoTemp20002016-09-01
M74450002StaFreez50002017-06-01
M74481001HemoCool Gel-Pak810081002018-01-10
M74490001HemoTemp II Activator90002017-06-01
M74461001LabTemp 4061002017-06-01
M74410004TempTrend10002016-09-01
M74411001TempTrend II11002016-09-01
M74410001TempTrend10002016-09-01
M74430001HemoTemp II30002017-02-08
M74460002LabTemp 2060002017-06-01
M74410002TempTrend10002016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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