FDA.reportPublic FDA data

IHC

Primary DI
00810170551994
Brand
IHC
Company
Slmp, LLC
Model
(BTO) Manual H pylori Polyclonal Antibody (25ml)
Catalog number
RP01-25
Device description
H. Pylori (P), 25mL
Published
2025-03-06
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
00810170551994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810170551994008101705519948101705519940810170551994

GMDN Terms#

Term, Definition table
TermDefinition
Helicobacter pylori antigen IVD, antibodyOne or multiple immunoglobulins with the capability of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of antigens from Helicobacter pylori bacteria 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

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Primary DI, Brand, Company table
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00846405000005Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-05-01
00846405000012Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-05-01
00846405000029Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-05-01
00847627040664SALL4BIOCARE MEDICAL LLCNJT2026-04-01
00847627041036Cyclin D1BIOCARE MEDICAL LLCNJT2026-04-01
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07613336226568VENTANA® U6 DIG ProbeVentana Medical Systems, Inc.NJT2026-03-26
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00847627042156CDH17 (M)BIOCARE MEDICAL LLCNJT2025-11-19
00847627042552Epithelial Membrane Antigen (EMA) [E29] BIOCARE MEDICAL LLCNJT2025-11-19
00847627042675CDX2 (RM)BIOCARE MEDICAL LLCNJT2025-11-19
00847627042736IgG4 (M)BIOCARE MEDICAL LLCNJT2025-11-19
00847627040640p53BIOCARE MEDICAL LLCNJT2025-11-10
00847627041975DOG1BIOCARE MEDICAL LLCNJT2025-11-10
00847627042811CD19 (RM) [RM332]BIOCARE MEDICAL LLCNJT2025-10-31
00847627041562Glutamine SynthetaseBIOCARE MEDICAL LLCNJT2025-10-23
00847627041609Cytokeratin 17 (CK17)BIOCARE MEDICAL LLCNJT2025-10-23
07613336234365VENTANA HER2 (CAL27) AssayVentana Medical Systems, Inc.NJT2025-10-21
00847627041821Lambda Light Chain [N10/2]BIOCARE MEDICAL LLCNJT2025-10-21
00847627041883Cytokeratin 5 (CK5)BIOCARE MEDICAL LLCNJT2025-10-21
07613336234433TRPS1 (SP532) Rabbit Monoclonal AntibodyVentana Medical Systems, Inc.NJT2025-10-16
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