FDA.reportPublic FDA data

IHC

Primary DI
00810170553608
Brand
IHC
Company
Slmp, LLC
Model
Primary Antibody Diluent
Catalog number
ACR-018
Device description
Primary Antibody Diluent, 250 mL
Published
2025-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00810170553608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810170553608008101705536088101705536080810170553608

GMDN Terms#

Term, Definition table
TermDefinition
Immunohistochemistry antibody diluent IVDA substance or reactant intended to be used for the dilution of antibody solution for use in an enzyme immunohistochemistry assay performed on biological tissues or clinical specimens.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118544521
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810170553585IHC10X Tris-EDTA Retrieval Buffer, pH 9.0ACR-0032025-03-31
00810170553592IHCImmuno Wash Buffer, 10XACR-0152025-03-31
00810170553615IHCProteinase KACR-0192025-03-31
00810170553622IHC007 ImmunoWash (10x) 1LACR-0242025-03-31
00810170553639IHCFITC Diluent (100mL)ACR-0342025-03-31
00810170553646IHCUltra High Def Red-AP Chromogen (110ml)CRM-005-1102025-03-31
00810170550300IHCMelanoma (HMB45) Antibody (10ml)MM100-102025-03-14
00810170550317IHC(BTO) Manual Melanoma (HMB45) Antibody (6ml)MM100-62025-03-14
00810170550324IHC(BTO) RTU Melanoma Cocktail Antibody (10ml)MM101-102025-03-14
00810170552328IHC(BTO) Manual Melanoma (HMB45) Antibody (2ml)SAM-MM100-22025-03-14
00810170552335IHC(BTO) Sample Melanoma Cocktail Antibody (2ml)SAM-MM101-22025-03-14
00810170552922IHC(BTO) Sample CEA Carcinoembryonic Antigen AntibodySAM-MM41-22025-03-14
00810170552939IHC(BTO) Sample Cyclin E Protein (HE12) Antibody (2mlSAM-MM44-22025-03-14
00810170552946IHC(BTO) Sample CK Cytokeratin (AE1/AE3) Antibody (2mSAM-MM45-22025-03-14
00810170552953IHC(BTO) Sample RTU Cytokeratin HMW High Molecular WeSAM-MM46-22025-03-14
00810170552960IHC(BTO) Sample CK Cytokeratin Antibody (2ml)SAM-MM48-22025-03-14
00810170552977IHC(BTO) Sample Cytokeratin AE1 Acidic (AE1) AntibodySAM-MM49-22025-03-14
00810170552984IHC(BTO) Sample Cytokeratin AE3 Basic (AE3) Antibody SAM-MM50-22025-03-14
00810170552991IHC(BTO) Sample Cytokeratin CAM 5.2 Antibody (2ml)SAM-MM51-22025-03-14
00810170553004IHC(BTO) Sample Cytokeratin 14 Antibody (2ml)SAM-MM52-22025-03-14

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