FDA.reportPublic FDA data

Dewax Solution

Primary DI
08435804515092
Brand
Dewax Solution
Company
VITRO SA
Model
MAD-004080VSBC
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
08435804515092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435804515092084358045150928435804515092

GMDN Terms#

Term, Definition table
TermDefinition
Dewaxing solution IVDA substance intended to be used to remove paraffin wax from formalin-fixed, paraffin-embedded biological tissues or clinical specimens for subsequent in vitro diagnostic (IVD) testing.

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
08435421272927Cleaning Solution 10XMAD-003931CSVS2025-02-20
08435421272934Dewax SolutionMAD-004080VS2025-02-20
08435421272972High-ARMAD-004075VS2025-02-20
08435421273047DAB EnhancerMAD-001560QVS2025-02-20
08435421273085CoverMAD-003983VS2025-02-20

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
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
05407010129342NTT-001-R : 150 mM NaCl - 1L bag SAMPLELonza VerviersPPM2025-10-30