AccessGUDID - DEVICE: BD Affirm™ VPIII Microbial Identification Test (00382904462529)

GUDID

Device Identifier (DI) Information

Brand Name: BD Affirm™ VPIII Microbial Identification Test
Version or Model: 446252
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 446252
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382904462529
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD Affirm™ VPIII Microbial Identification Test

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
48208	Multiple-type 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 multiple types of 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MJK	DNA PROBE, TRICHOMONAS VAGINALIS
MJM	DNA PROBE, GARDNERELLA VAGINALIS
MLA	DNA PROBE, YEAST

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 73cca7d7-b495-40dd-b2bb-e93e8a11ddb8
Public Version Date: April 26, 2024
Public Version Number: 3
DI Record Publish Date: May 25, 2018