FDA.reportPublic FDA data

HER2 IQFISH pharmDx™

Primary DI
05700572032465
Brand
HER2 IQFISH pharmDx™
Company
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
Model
K5731
Device description
HER2 IQFISH pharmDx™
Published
2014-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MVDSystem, Test, Her-2/Neu, Nucleic Acid Or Serum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVDSystem, Test, Her-2/Neu, Nucleic Acid Or SerumUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P040005001

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P040005001DAKOCYTOMATION HER2 FISH PHARMDX KITAgilent Technologies Singapore (International) Pte , Ltd.2005-05-03MVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700572032465PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700572032465057005720324655700572032465

GMDN Terms#

Term, Definition table
TermDefinition
Her2/neu/erbB2 mRNA expression IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of mRNA expression of the Her2/neu/erbB2 (v-erb-B2 avian erythroblastic leukaemia viral oncogene homolog 2) gene in a tumour tissue specimen, using a nucleic acid technique (NAT).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Storage Environment Temperature0 Degrees Celsius-18 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
894671143
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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05700572027799Poly Rb A-Hu Alpha-1-FetoproteinA00082020-09-17
05700572005841Mono Mo A-Hu CD35 Cl Ber-MAC-DRCM08462020-09-17
05700572004912Mono Mo A-Vimentin Cl V9M07252020-09-17
05700572027942Mono Mo A-Vimentin Cl V9M07252020-09-17
05700572516170Mono Mo A-Epstein-Barr Virus, LMP Cls CS. 1-4M08972020-09-17
05700571112182DakoGC1182025-09-02
05700575013812Dako Omnis DI Water Filling AccessoriesGC1212025-06-25
05700575014017Dako Omnis Clean Liquid System HardwareGC1222025-06-25
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05700575014048Dako Omnis Waste Tank (Hz)GC1272025-06-25
05700575014413Dako Omnis Waste Accessories (Direct)GC1232025-06-25
05700575014420Dako Omnis Waste Accessories (Indirect)GC1242025-06-25
05700572007340Poly Rb A-Hu IgG/HRPP02142016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884999001732PathVysionABBOTT MOLECULAR INC.MVD2014-11-20
00884999001756PathVysionABBOTT MOLECULAR INC.MVD2014-11-20
00884999001763PathVysionABBOTT MOLECULAR INC.MVD2014-11-20