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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846405020331Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-04-30
10845357044409Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.PPM2026-04-15
08435804523417Master Polymer Plus Detection System (Phosphatase)VITRO SAPPM2026-04-07
08435804524551Master Polymer Plus Detection System (Phosphatase)VITRO SAPPM2026-04-07
05407010128222Bulk Packaged ster. filtered WFI - 500mlLonza VerviersPPM2026-03-30
054070101286350.1 M NaCl Module L : 1L Bag SAMPLELonza VerviersPPM2026-03-30
05407010129861T-32 1000L bagLonza VerviersPPM2026-03-26
05407010129878T-32 200L bagLonza VerviersPPM2026-03-26
05407010129885NaAc-35 - 1000L bagLonza VerviersPPM2026-03-26
05407010129892NaAc-35 - 200L BagLonza VerviersPPM2026-03-26
05407010129908NaAc-35 -1L Sample bagLonza VerviersPPM2026-03-26
05407010129915NaP-55 - 1000LLonza VerviersPPM2026-03-26
05407010129922NaP-55 - 1L sample bagLonza VerviersPPM2026-03-26
05407010129939NaAc-36 -1000L BagLonza VerviersPPM2026-03-26
05407010129946NaAc-36 -1L Sample BagLonza VerviersPPM2026-03-26
05407010129953NaAc-36 -500L BagLonza VerviersPPM2026-03-26
05407010129960NaAc-34 -1000L BagLonza VerviersPPM2026-03-26
00630414289984Atellica HEMA CleanerSiemens Healthcare Diagnostics Inc.PPM2026-02-06
00630414290034Atellica HEMA DeconSiemens Healthcare Diagnostics Inc.PPM2026-02-06
04049016152019EUROSORB (IFA)EUROIMMUN Medizinische Labordiagnostika AGPPM2025-11-21
05407010129243KH-020 BF-1 1L Sample BagLonza VerviersPPM2025-10-30
05407010129250KH-020 BF-1 1000L BagLonza VerviersPPM2025-10-30
05407010129267KH-020 BF-1 500L BagLonza VerviersPPM2025-10-30
05407010129274NTT-001-L Buffer - 1L bag SAMPLELonza VerviersPPM2025-10-30
05407010129281NTT-001-L Buffer - 200L bagLonza VerviersPPM2025-10-30
05407010129298NTT-001-L Buffer - 500L bagLonza VerviersPPM2025-10-30
05407010129304NTT-001-K : 1M NaCl - 1L bag SAMPLELonza VerviersPPM2025-10-30
05407010129311NTT-001-K : 1M NaCl - 200L bagLonza VerviersPPM2025-10-30
05407010129328NTT-001-K : 1M NaCl - 500L bagLonza VerviersPPM2025-10-30
05407010129335NTT-001-R : 150 mM NaCl - 1000L bagLonza VerviersPPM2025-10-30