FDA.reportPublic FDA data

IHC

Primary DI
00810170553028
Brand
IHC
Company
Slmp, LLC
Model
(BTO) Sample CK20 Cytokeratin 20 (KS 20.8) Antibod
Catalog number
SAM-MM55-2
Published
2025-03-14
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
NJTImmunohistochemistry Reagents And Kits

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810170553028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810170553028008101705530288101705530280810170553028

GMDN Terms#

Term, Definition table
TermDefinition
Cytokeratin IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of one or multiple cytokeratin subtype(s) in a clinical specimen.

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
00810170553608IHCPrimary Antibody DiluentACR-0182025-03-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841683151340Arginase-1 SP156 Rab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151364CD163 MRQ-26 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151371Cytokeratin 5 & 6 D5 & 16B4 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151388Ep-CAM MOC31 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151395GATA3 L50-823 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151401Glypican-3 1G12 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151418Hepatocyte Specific Antigen (Hep-Par 1) OCH1E5 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151425IgG4 MRQ-44 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151432Mammaglobin 31A5 Rab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151449Microphthalmia Transcription Factor (MiTF) C5/D5 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151463Napsin A MRQ-60 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151470p120 Catenin MRQ-5 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151487PAX8 MRQ-50 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151494PHH3 PolyclonalCELL MARQUE CORPORATIONNJT2026-09-04
00841683151517Podoplanin D2-40 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151524Renal Cell Carcinoma PN-15 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151531S100 Protein 4C4.9 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151548SOX-10 PolyclonalCELL MARQUE CORPORATIONNJT2026-09-04
00841683151555SOX-11 MRQ-58 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151562SOX-2 SP76 Rab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151579C4d SP91 Rab.CELL MARQUE CORPORATIONNJT2026-09-04
04065271108967Claudin-4 (EP417) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATIONNJT2026-09-04
00846405016808Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405016822Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405016839Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405016846Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405020102Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405020119Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405020126Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405020133Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09