FDA.reportPublic FDA data

Cleaning Solution 10X

Primary DI
08435421272927
Brand
Cleaning Solution 10X
Company
VITRO SA
Model
MAD-003931CSVS
Published
2025-02-20
Public version status
New
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
08435421272927PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435421272927084354212729278435421272927

GMDN Terms#

Term, Definition table
TermDefinition
Wash/cleaning solution IVD, automated/semi-automated systemA concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
466076718
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
08435804523417Master Polymer Plus Detection System (Phosphatase)MAD-000230QKVSBC2026-04-07
08435804524551Master Polymer Plus Detection System (Phosphatase)MAD-000230QKVS2026-04-07
08435804522199FISH PT KITMAD-004082VS2026-01-15
08435804522212DEWAX-2 FISHMAD-004081VS2026-01-15
08435804522366FISH PT KITMAD-004082VSBC2026-01-15
08435804522397DEWAX-2 FISH MAD-004081VSBC2026-01-15
08435804520706Pepsin for antigen retrieval (RTU)MAD-024081RVS2025-08-08
08435804520713Proteinase K (RTU)MAD-011892QEVS2025-08-08
08435804522328Proteinase K (RTU)MAD-011892QEVSBC2025-08-08
08435804522335Pepsin for antigen retrieval (RTU)MAD-024081RVSBC2025-08-08
08435804522342Master Dual Staining KitMAD-001882QPVS2025-08-08
08435804522359Master Dual Staining KitMAD-001882QPVSBC2025-08-08
08435804518970NeoPATH ProVIT-VS42BC2025-02-20
08435256719499TBS Tween 20 Buffer 10X q.s. 10LMAD-004077R-102025-02-20
08435421271890VitroStainer 42VIT-VS422025-02-20
08435421272934Dewax SolutionMAD-004080VS2025-02-20
08435421272972High-ARMAD-004075VS2025-02-20
08435421273047DAB EnhancerMAD-001560QVS2025-02-20
08435421273085CoverMAD-003983VS2025-02-20
08435421273498Contrast Hematolxylin HDH3MAD-HDH3-100VS2025-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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00846405012565Diagnostic 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