FDA.reportPublic FDA data

BOND™

Primary DI
05055331321589
Brand
BOND™
Company
LEICA BIOSYSTEMS NEWCASTLE LTD
Model
PA0410
Catalog number
PA0410
Device description
Ki67 (MM1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Ki67 nuclear antigen in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
Published
2021-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
05055331321589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055331321589050553313215895055331321589

GMDN Terms#

Term, Definition table
TermDefinition
Ki67 antigen 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 Ki67 antigen in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)2480123tech.support@leicabiosystems.com

Regulatory Flags#

DUNS number
397134693
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
05055331339607BONDPA0678-UPA0678-U2026-04-10
05055331316967Novocastra™AE1/AE3-L-CENCL-L-AE1/AE32022-12-07
08718858480791Kreatech FISH probes22Q003B4952022-09-21
08718858481231Kreatech FISH probes02P009V5502022-09-21
08718858481248Kreatech FISH probes03Q009V49503Q009V4952022-09-21
08718858481774Kreatech FISH probes02P008V4952022-09-21
08718858481668Kreatech FISH probes03Q001B5502022-08-08
08718858481675Kreatech FISH probes03Q002B4952022-08-08
08718858481712Kreatech FISH probes13Q002C4952022-08-08
08718858481729Kreatech FISH probes14Q001C4152022-08-08
08718858481736Kreatech FISH probes16Q001B4952022-08-08
08718858481743Kreatech FISH probes23P004C5502022-08-08
08718858481798Kreatech FISH probes04Q001B5502022-08-08
08718858481804Kreatech FISH probes04Q005B5502022-08-08
08718858481811Kreatech FISH probes08C001B4952022-08-08
08718858481880Kreatech FISH probes01P003B5502022-08-08
08718858481958Kreatech FISH probes04C001B4952022-08-08
08718858480029Kreatech FISH probes06Q003B4952022-08-05
08718858480036Kreatech FISH probes10Q001B4952022-08-05
08718858481613Kreatech FISH probes14Q001B5502022-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336236987VENTANA CD15 (MMA.P8) Mouse Monoclonal AntibodyVentana Medical Systems, Inc.NJT2026-05-18
00847627051622CK HMW + p63 + AMACR (RM)BIOCARE MEDICAL LLCNJT2026-05-14
00847627051639CK HMW + p63 + AMACR (RM)BIOCARE MEDICAL LLCNJT2026-05-14
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
00847627042095Carcinoembryonic Antigen (CEA{M})BIOCARE MEDICAL LLCNJT2026-04-01
00847627042194Caspase-3 (Cleaved)BIOCARE MEDICAL LLCNJT2026-04-01
00847627042590S100PBIOCARE MEDICAL LLCNJT2026-04-01
00847627042859CD33BIOCARE MEDICAL LLCNJT2026-04-01
07613336226568VENTANA® U6 DIG ProbeVentana Medical Systems, Inc.NJT2026-03-26
00847627041500Uroplakin II + Uroplakin IIIBIOCARE MEDICAL LLCNJT2025-11-19
00847627041845SOX11 (M)BIOCARE MEDICAL LLCNJT2025-11-19
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
00847627040008HMB45 + MART-1 + TyrosinaseBIOCARE MEDICAL LLCNJT2025-10-10
00847627040015HMB45 + MART-1 + TyrosinaseBIOCARE MEDICAL LLCNJT2025-10-10