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
Primary DIBrandModelCatalogPublished
05700572515890Mono Mo A-Hu CD34 Class III/FITC Cl BIRMA-K3F70812020-09-17
05700572005049Mono Mo A-Rb Immunoglobulins Cl MR12/53M07372020-09-17
05700572005339Mono Mo A-Hu Amyloid A Cl mc1M07592020-09-17
05700572006428Mono Mo A-Hu Carcinoembryonic Antigen Cl II-7M70722020-09-17
05700572005100Mono Mo A-Hu CD45R0 Cl UCHL1M07422016-09-16
05700572005599Mono Mo A-Hu Prostatic Acid Phosphatase Cl PASE/4LJM07922020-09-17
05700572006305Mono Mo A-Cytokeratin 17 Cl E3M70462020-09-17
05700572018735Ig Reagent Rb F(ab')2/APCX09982020-09-17
05700572024613Mono Mo A-Hu CD22/APC Cl 4KB128C72812020-09-17
05700572024774Mono Mo a Hu CD61, Platelet Glycoprotein IIIa/APC, Cl Y2/51C72802020-09-17
05700572033929Mono Mo a Hu CD45R0/RPE, Cl UCHL1R08432020-09-17
05700572033936Mono Mo a Hu CD3/PB, Cl UCHT1PB9822020-09-17
05700572033950Mono Mo a Hu CD8/PB, Cl DK25PB9842020-09-17
05700572515258Mono Mo a Hu CD41, Platelet Glycoprotein IIb/RPE, Cl 5B12R70582020-09-17
05700572515432Mono Mo a Hu CD79ß/RPE, Cl SN8R72722020-09-17
05700572515715Mono Mo A-Hu CD7/FITC Cl DK24F07892020-09-17
05700572515746Mono Mo A-Hu CD25, Interleukin-2 Receptor/FITC Cl ACT-1F08012020-09-17
05700572516255Mono Mo a Hu CD5/RPE, Cl DK23R08422020-09-17
05700572516279Mono Mo a Hu CD14/RPE, Cl TÜK4R08642020-09-17
05700572516309Mono Mo a Hu CD16, Fc Gamma Receptor III/RPE, Cl DJ130cR70122020-09-17

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