FDA.reportPublic FDA data

BOND™

Primary DI
05055331303882
Brand
BOND™
Company
LEICA BIOSYSTEMS NEWCASTLE LTD
Model
PA0704
Catalog number
PA0704
Device description
Human Growth Hormone (Polyclonal) antibody is intended to be used for the qualitative identification by light microscopy of human growth hormone 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
2021-04-23
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
05055331303882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055331303882050553313038825055331303882

GMDN Terms#

Term, Definition table
TermDefinition
Human growth hormone (HGH) 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 human growth hormone (HGH) 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
05055331334725BOND™PA0258-UPA0258-U2022-12-16
05055331315229Novocastra™CBE-356-L-CENCL-L-CBE-3562022-12-07
05055331302038Novocastra™RE7120-CERE7120-K2021-05-17
05055331311788Novocastra™CK20-561-L-CENCL-L-CK20-5612021-04-23
05055331304407BOND™PA0258PA02582021-04-16
05055331321206Novocastra™MSA-L-UNCL-L-MSA2021-04-16
05055331303752BOND™PA0934PA09342021-04-09
05055331303783BOND™PA0906PA09062021-03-12
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

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