AccessGUDID - DEVICE: Aptima® (15420045506800)

GUDID

Device Identifier (DI) Information

Brand Name: Aptima®
Version or Model: KIT, CALIBRATOR, HCV QUANT, US IVD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PRD-03707
Company Name: Hologic, Inc.

Primary DI Number: 15420045506800
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 050579217 *Terms of Use

Device Description: Aptima® HCV Quant Dx Assay Calibrator.

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?
41979	Hepatitis C virus 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 Hepatitis C virus nucleic acid in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MZP	ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160023	001
P160023	009
P160023	015
P160023	016

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: e72a281c-8fed-4812-8518-1023df6f2773
Public Version Date: July 22, 2024
Public Version Number: 6
DI Record Publish Date: March 08, 2017