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

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00382904003739BD Whitacre Spinal4003734003732023-09-02
00382904003821BD Whitacre Spinal4003824003822023-09-02
30382903666042BD MiniDraw™ SST™ Capillary Blood Collection Tube3666043666042024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, Small3666133666132024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, Medium3666143666142024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, Large3666153666152024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-Large3666163666162024-06-06
30382903666172BD MiniDraw™ Finger Sizing Tool3666173666172024-06-06
00382904003715BD Whitacre Spinal4003714003712023-09-02
00382904003722BD Whitacre Spinal4003724003722023-09-02
00885403522270Swan-Ganz131F7P2026-05-30
00885403522348SWAN-GANZ CCOMBO V777F82026-05-30

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