AccessGUDID - DEVICE: Aptima® (15420045514577)

GUDID

Device Identifier (DI) Information

Brand Name: Aptima®
Version or Model: CMV, CALIBRATOR KIT, APTIMA, IVD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PRD-05075
Company Name: Hologic, Inc.

Primary DI Number: 15420045514577
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 050579217 *Terms of Use

Device Description: Aptima® CMV Quant Assay Calibrators Kit.

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?
41764	Cytomegalovirus (CMV) nucleic acid IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from cytomegalovirus (CMV) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PAB	Cytomegalovirus (cmv) dna quantitative assay

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K243935	000
P210029	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 -35 and -15 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5fa9da52-ad49-4250-a029-30e775ecf3f4
Public Version Date: February 21, 2025
Public Version Number: 3
DI Record Publish Date: June 01, 2022