AccessGUDID - DEVICE: Aptima® (15420045507210)

GUDID

Device Identifier (DI) Information

Brand Name: Aptima®
Version or Model: KIT, BOX 1, REFRIG, AHSV, 100T, IVD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ASY-08088
Company Name: Hologic, Inc.

Primary DI Number: 15420045507210
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 050579217 *Terms of Use

Device Description: Aptima® HSV 1 & 2 Assay, 100 test, box 1 of 2 (2°C to 8°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?
49539	Herpes simplex virus 1 & 2 (HSV1 & 2) 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 herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen, using a nucleic acid technique (NAT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OQO	Herpes simplex virus nucleic acid amplification assay

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162673	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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 76325187-33da-445b-9722-bed43f64fb85
Public Version Date: November 30, 2023
Public Version Number: 5
DI Record Publish Date: June 23, 2017