FDA.reportPublic FDA data

ThermoBrite

Primary DI
00849832002109
Brand
ThermoBrite
Company
Leica Biosystems Richmond, Inc.
Model
3800-004852-004
Published
2017-09-19
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
00849832002109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849832002109008498320021098498320021090849832002109

GMDN Terms#

Term, Definition table
TermDefinition
Microscope slide hybridization/denaturation incubator IVDA mains electricity (AC-powered) laboratory instrument intended to be used for the incubation of microscope slides for the denaturation and/or hybridization of a clinical specimen as part of an in situ hybridization (ISH) and/or fluorescence in situ hybridisation (FISH) protocol. It is typically a bench-top unit with the capacity to hold multiple previously-prepared slides (i.e., fixed slides with/without added reagents) and is programmable to provide an optimum environment for ISH/FISH procedures (e.g., by controlling temperature, humidity and incubation time).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)5342262tech.support@Leicabiosystems.com

Regulatory Flags#

DUNS number
082930884
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10849832027819Leica Biosystems380320038032002026-05-22
20849832027915Leica Biosystems39LP-200-239LP-200-22026-05-13
20849832027946Leica Biosystems39LP-200-539LP-200-52026-05-13
20849832027908Leica Biosystems39LP-200-139LP-200-12026-05-12
20849832027922Leica Biosystems39LP-200-339LP-200-32026-05-12
20849832027939Leica Biosystems39LP-200-439LP-200-42026-05-12
20849832027953Leica Biosystems39LP-200-639LP-200-62026-05-12
20849832027960Leica Biosystems39LP-200-739LP-200-72026-05-12
20849832027977Leica Biosystems39LP-300-039LP-300-02026-05-12
20849832027984Leica Biosystems39LP-300-139LP-300-12026-05-12
20849832027991Leica Biosystems39LP-300-239LP-300-22026-05-12
20849832028004Leica Biosystems39LP-300-339LP-300-32026-05-12
20849832028011Leica Biosystems39LP-300-439LP-300-42026-05-12
20849832028028Leica Biosystems39LP-300-539LP-300-52026-05-12
20849832028035Leica Biosystems39LP-300-639LP-300-62026-05-12
20849832028042Leica Biosystems39LP-300-739LP-300-72026-05-12
20849832028059Leica Biosystems39LP-400-039LP-400-02026-05-12
20849832028066Leica Biosystems39LP-400-139LP-400-12026-05-12
20849832028073Leica Biosystems39LP-400-239LP-400-22026-05-12
20849832028080Leica Biosystems39LP-400-339LP-400-32026-05-12

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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