FDA.reportPublic FDA data

VENTANA HE 600 Wash

Primary DI
04015630974795
Brand
VENTANA HE 600 Wash
Company
Ventana Medical Systems, Inc.
Model
06544312001
Catalog number
06544312001
Published
2021-02-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04015630974795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630974795040156309747954015630974795

GMDN Terms#

Term, Definition table
TermDefinition
Kappa/lambda light chain messenger RNA IVD, probeA defined piece of single-stranded nucleic acid which is used to identify specific complementary-sequence nucleic acid molecules in an assay intended to be used for the qualitative and/or quantitative detection of kappa and/or lambda light chain messenger RNA in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184042521
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336239025VENTANA MTAP (SP530) Rabbit Monoclonal Antibody10574518001105745180012026-06-08
07613336236987VENTANA CD15 (MMA.P8) Mouse Monoclonal Antibody10496410001104964100012026-05-18
07613336239063Congo Red Stain Core Kit10585021001105850210012026-04-10
07613336239544Gram Stain Core Kit10608358001106083580012026-04-10
04015630984787SSR Solution06890059001068900590012021-02-03
07613336226568VENTANA® U6 DIG Probe10062746001100627460012026-03-26
07613336240281ASSY RGT DSPNR CARD BMK PREP KIT 30110637412001106374120012026-03-20
07613336240298ASSY RGT DSPNR CARD BMK PREP KIT 30210637439001106374390012026-03-20
07613336240304ASSY RGT DSPNR CARD BMK PREP KIT 30310637447001106374470012026-03-20
07613336240311ASSY RGT DSPNR CARD BMK PREP KIT 30410637455001106374550012026-03-20
07613336240328ASSY RGT DSPNR CARD BMK PREP KIT 30510637463001106374630012026-03-20
07613336240335ASSY RGT DSPNR CARD BMK PREP KIT 30610637471001106374710012026-03-20
07613336240342ASSY RGT DSPNR CARD BMK PREP KIT 30710637480001106374800012026-03-20
07613336240359ASSY RGT DSPNR CARD BMK PREP KIT 30810637498001106374980012026-03-20
07613336240366ASSY RGT DSPNR CARD BMK PREP KIT 30910637501001106375010012026-03-20
07613336240373ASSY RGT DSPNR CARD BMK PREP KIT 31010637536001106375360012026-03-20
07613336240380ASSY RGT DSPNR CARD BMK PREP KIT 31110637544001106375440012026-03-20
07613336240397ASSY RGT DSPNR CARD BMK PREP KIT 31210637552001106375520012026-03-20
07613336240403ASSY RGT DSPNR CARD BMK PREP KIT 31310637579001106375790012026-03-20
07613336240410ASSY RGT DSPNR CARD BMK PREP KIT 31410637587001106375870012026-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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00846405012473Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012497Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
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00846405013432Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
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00846405016778Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
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00846405017140Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405023219Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405023271Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08