AccessGUDID - DEVICE: Aptima® (15420045500129)

GUDID

Device Identifier (DI) Information

Brand Name: Aptima®
Version or Model: KIT, APTIMA HPV 16 18/45, 100 RT IVD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 303231
Company Name: Hologic, Inc.

Primary DI Number: 15420045500129
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 050579217 *Terms of Use

Device Description: Aptima® HPV 16 18/45 Genotype Assay, 100 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 [?]
P120007	001
P120007	002
P120007	003
P120007	011
P120007	018
P120007	019
P120007	022
P120007	025
P120007	026
P120007	029
P120007	030

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: 515d32aa-3b13-4784-8f8f-0ef8f00af16a
Public Version Date: June 13, 2024
Public Version Number: 3
DI Record Publish Date: July 30, 2014

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)442-9892
Email: CustomerSupport@hologic.com

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