AccessGUDID - DEVICE: Aptima® (15420045500068)

GUDID

Device Identifier (DI) Information

Brand Name: Aptima®
Version or Model: KIT,HPV,APTIMA,250 TEST,ROOM TEMP, IVD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 302885
Company Name: Hologic, Inc.

Primary DI Number: 15420045500068
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 050579217 *Terms of Use

Device Description: Aptima® HPV Assay, 250 test, box 2 of 2 (15°C to 30°C box).

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:	No
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?
49997	Human papillomavirus (HPV) high risk strain 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 high-risk strains of human papillomavirus (HPV) associated with cervical cancer, which may include types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and/or 68 in a clinical specimen, using a nucleic acid technique (NAT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OYB	Kit, rna detection, human papillomavirus

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P100042	001
P100042	002
P100042	004
P100042	012
P100042	013
P100042	020
P100042	022
P100042	024
P100042	027
P100042	028
P100042	032
P100042	034

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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 68160f35-36d0-4811-910e-2f4e0e4e5a7e
Public Version Date: June 13, 2024
Public Version Number: 4
DI Record Publish Date: July 30, 2014