FDA.reportPublic FDA data

BD ProbeTec™ Herpes Simplex Viruses Assays Reagent Pack

Primary DI
00382904417499
Brand
BD ProbeTec™ Herpes Simplex Viruses Assays Reagent Pack
Company
BECTON, DICKINSON AND COMPANY
Model
441749
Catalog number
441749
Device description
Kit HSV 1/Hsv2 Qx Amplified Dna Assay
Published
2016-07-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OQOHerpes simplex virus nucleic acid amplification assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OQOHerpes Simplex Virus Nucleic Acid Amplification AssayMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103798000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103798000BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYSBecton, Dickinson & CO2011-03-18OQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904417499PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904417499003829044174993829044174990382904417499

GMDN Terms#

Term, Definition table
TermDefinition
Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid 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 nucleic acid from herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen, using a nucleic acid technique (NAT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius33 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags#

DUNS number
122561087
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382906718167Horizon6718166718162026-09-24
00382906718174Horizon6718176718172026-09-24
00382906718181Horizon6718186718182026-09-24
00382906718198Horizon6718196718192026-09-24
00382906718204Horizon6718206718202026-09-24
00382906718211Horizon6718216718212026-09-24
00382906718235Horizon6718236718232026-09-24
00382906718242Horizon6718246718242026-09-24
00382906718259Horizon6718256718252026-09-24
00382906718266Horizon6718266718262026-09-24
00382906718273Horizon6718276718272026-09-24
00382906718280Horizon6718286718282026-09-24
00382906718310Horizon6718316718312026-09-24
00382906718327Horizon6718326718322026-09-24
00382906718334Horizon6718336718332026-09-24
00382906718341Horizon6718346718342026-09-24
00382906718358Not Applicable6718356718352026-09-24
00382906718365Horizon6718366718362026-09-24
00382906718372Horizon6718376718372026-09-24
00382906718389Horizon6718386718382026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08885013953664Sentosa SA201 HSV-1/2 PCR TestVELA OPERATIONS SINGAPORE PTE. LTD.OQO2018-04-16
25420045510187Aptima®Hologic, Inc.OQO2018-01-16
15420045507210Aptima®Hologic, Inc.OQO2017-06-23
15420045507227Aptima®Hologic, Inc.OQO2017-06-23
15420045507234Aptima®Hologic, Inc.OQO2017-06-23
25420045507248Aptima®Hologic, Inc.OQO2017-02-16
04053228004660artus® HSV-1/2 QS-RGQ MDx KitQIAGEN GmbHOQO2017-01-04
00875197004434cobas® 4800 System Lysis KitRoche Molecular Systems, Inc.OQO2016-09-24
00875197004458cobas® 4800 Systems Internal Control KitRoche Molecular Systems, Inc.OQO2016-09-24
00875197005264cobas® 4800 System Lysis KitRoche Molecular Systems, Inc.OQO2016-09-24
20816101025507Simplexa™ HSV 1 & 2 DirectDIASORIN MOLECULAR LLCOQO2016-09-22
20816101025514Simplexa™ HSV 1 & 2 Positive Control PackDIASORIN MOLECULAR LLCOQO2016-09-22
30014613312109AmpliVueQUIDEL CORPORATIONOQO2016-09-15
00840487101032Mutlicode®-RTx HSV 1&2 KitLUMINEX CORPORATIONOQO2016-09-09
00382904417482Control Set for the BD ProbeTec™ Herpes Simplex VirusesBECTON, DICKINSON AND COMPANYOQO2016-07-07