FDA.reportPublic FDA data

BD Affirm™ VPIII Microbial Identification Test

Primary DI
00382904462529
Brand
BD Affirm™ VPIII Microbial Identification Test
Company
BECTON, DICKINSON AND COMPANY
Model
446252
Catalog number
446252
Device description
BD Affirm™ VPIII Microbial Identification Test
Published
2018-05-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MJKDNA PROBE, TRICHOMONAS VAGINALIS
MJMDNA PROBE, GARDNERELLA VAGINALIS
MLADNA PROBE, YEAST

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJKDna Probe, Trichomonas VaginalisMicrobiology1
MJMDna Probe, Gardnerella VaginalisMicrobiology1
MLADna Probe, YeastMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904462529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904462529003829044625293829044625290382904462529

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
Special Storage Condition, Specify00Collection date
Special Storage Condition, Specify00Collection time
Special Storage Condition, Specify00P403 – Store in a well-ventilated place.
Special Storage Condition, Specify00P405 – Store locked up.
Special Storage Condition, Specify00Peel here
Storage Environment Temperature2 Degrees Celsius8 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
Kit
true
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
10198956102217CARDINAL HEALTHCardinal Health 200, LLCMLA2025-06-05
50198956102215CARDINAL HEALTHCardinal Health 200, LLCMLA2025-06-05
10197106086612CARDINAL HEALTHCardinal Health 200, LLCMLA2022-12-15
10195594702809CARDINAL HEALTHCardinal Health 200, LLCMLA2022-05-31
50195594702807CARDINAL HEALTHCardinal Health 200, LLCMLA2022-05-31
10195594572495CARDINAL HEALTHCardinal Health 200, LLCMLA2022-02-21
50195594572493CARDINAL HEALTHCardinal Health 200, LLCMLA2022-02-21
00382904462574BD Affirm™ VPIII Microbial Identification TestBECTON, DICKINSON AND COMPANYMJK2018-05-25
00382904462574BD Affirm™ VPIII Microbial Identification TestBECTON, DICKINSON AND COMPANYMJM2018-05-25
00382904462574BD Affirm™ VPIII Microbial Identification TestBECTON, DICKINSON AND COMPANYMLA2018-05-25