FDA.reportPublic FDA data

Leica Biosystems

Primary DI
10849832003004
Brand
Leica Biosystems
Company
Leica Biosystems Richmond, Inc.
Model
000000000003803591
Device description
SelecTech Define Concentrate
Published
2024-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
PPMGeneral purpose reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849832003004PrimaryGS10
00849832017929Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084983200300410849832003004
00849832017929008498320179298498320179290849832017929

GMDN Terms#

Term, Definition table
TermDefinition
Biological stain IVDA single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.

Device Sizes#

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

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
+1(866)4783999tech.support@Leicabiosystems.com
+1(800)5374669tech.support@Leicabiosystems.com

Regulatory Flags#

DUNS number
082930884
Device count
4
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10849832001055Leica Biosystems39LC-705-439LC-705-42025-07-23
10849832003097Leica Biosystems39LC-705-339LC-705-32025-07-23
10849832024214Leica Biosystems380306538030652025-07-20
10849832024238Leica Biosystems380307538030752025-07-20
10849832024245Leica Biosystems380304538030452025-07-20
10849832024276Leica Biosystems380302538030252025-07-20
10849832025815Leica Biosystems39LC-705-139LC-705-12025-07-23
10849832025822Leica Biosystems39LC-705-239LC-705-22025-07-23
10849832025839Leica Biosystems39LC-705-539LC-705-52025-07-23
10849832027055Leica Biosystems380301538030152025-07-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04015630967162ISH Peroxidase InhibitorVentana Medical Systems, Inc.PPM2026-07-13
04049016151272FITC-labelled anti-human IgG (primate absorbed)EUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
04049016151289Biotin-labelled anti-human IgGEUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
04049016151296FITC-labelled Avidin (biotin affine)EUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
04049016151630FITC-labelled anti-human IgG (primate absorbed)EUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
00846405014194Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-09
00846405023417Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-09
00846405012305Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012312Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012329Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012411Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012428Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012435Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012459Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012466Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012473Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012497Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012503Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012510Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012527Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012534Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012541Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012558Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012565Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012589Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405013432Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405014163Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405014170Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405014200Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405016730Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08