FDA.reportPublic FDA data

BOND™

Primary DI
05055331303837
Brand
BOND™
Company
LEICA BIOSYSTEMS NEWCASTLE LTD
Model
PA0777
Catalog number
PA0777
Device description
Negative (Rabbit) is intended to be used as a rabbit negative control for qualitative immunohistochemical staining using an automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
Published
2021-05-07
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
05055331303837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055331303837050553313038375055331303837

GMDN Terms#

Term, Definition table
TermDefinition
Negative control immunoglobulin IVDA material containing immunoglobulin intended to be used in place of a primary antibody as a negative control to verify the performance of an assay that utilizes antibodies (e.g., immunoassay, immunohistochemistry or flow cytometry) and is performed on biological tissues or clinical specimens.

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
05055331330581BOND-PRIMECS9300CS93002026-07-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
05055331330581BOND-PRIMELEICA BIOSYSTEMS NEWCASTLE LTDNJT2026-07-08
00846405000166Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000173Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000180Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000678Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000685Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000692Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000760Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000777Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000784Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000791Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000807Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000814Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001156Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001163Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001170Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001187Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001194Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001200Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001309Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001316Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001323Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09