AccessGUDID - DEVICE: BD Control Set for the BD Onclarity™ HPV Assay (00382904440886)

GUDID

Device Identifier (DI) Information

Brand Name: BD Control Set for the BD Onclarity™ HPV Assay
Version or Model: 444088
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 444088
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382904440886
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: Control Set for the BD Onclarity™ HPV Assay

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: 3deee98b-2d45-4c6f-b8ad-4f24e2740ed6
Public Version Date: September 11, 2024
Public Version Number: 2
DI Record Publish Date: March 25, 2021