AccessGUDID - DEVICE: BD Onclarity™ HPV Liquid Based Cytology Specimen (LBC) Diluent Tubes (30382904438372)

GUDID

Device Identifier (DI) Information

Brand Name: BD Onclarity™ HPV Liquid Based Cytology Specimen (LBC) Diluent Tubes
Version or Model: 443837
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 443837
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382904438372
Issuing Agency: GS1
Commercial Distribution End Date: July 12, 2023
Device Count: 400
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD Onclarity™ HPV Liquid Based Cytology Specimen (LBC) Diluent Tubes

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:	No
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?
49994	Human papillomavirus (HPV) 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 strains of human papillomavirus (HPV) in a clinical specimen, using a nucleic acid technique (NAT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MAQ	KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160037	000

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 33 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ab8c5d44-1775-4099-a2da-268efa7b6bc2
Public Version Date: February 04, 2025
Public Version Number: 2
DI Record Publish Date: February 19, 2020