FDA.reportPublic FDA data

BD MAX™ Vaginal Panel

Primary DI
00382904437121
Brand
BD MAX™ Vaginal Panel
Company
BECTON, DICKINSON AND COMPANY
Model
443712
Catalog number
443712
Device description
BD MAX™ Vaginal Panel
Published
2017-03-23
Public version status
Update
Distribution status
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
NSUInstrumentation For Clinical Multiplex Test Systems
OOIReal Time Nucleic Acid Amplification System
OUYTrichomonas Vaginalis Nucleic Acid Amplification Test System
PQAVaginitis And Bacterial Vaginosis Nucleic Acid Detection System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSUInstrumentation For Clinical Multiplex Test SystemsClinical Chemistry2
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2
OUYTrichomonas Vaginalis Nucleic Acid Amplification Test SystemImmunology2
PQAVaginitis And Bacterial Vaginosis Nucleic Acid Detection SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN160001000
K201017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN160001000BD MAX Vaginal Panel, BD MAX InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics)2016-10-28PQA
K201017000BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection KitGeneohm Sciences Canada, Inc. (Bd Life Sciences)2021-10-18PQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904437121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904437121003829044371213829044371210382904437121

GMDN Terms#

Term, Definition table
TermDefinition
Multiple vaginitis-associated organism 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 one or multiple organisms associated with vaginitis in a clinical specimen, using a nucleic acid technique (NAT). Organisms intended to be detected may include Candida or other yeast species, Gardnerella vaginalis and/or Trichomonas vaginalis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8006388663Technical_services@bd.com
+1(800)638-8663Technical_services@bd.com

Regulatory Flags#

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

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