AccessGUDID - DEVICE: Aptima® (15420045506770)

GUDID

Device Identifier (DI) Information

Brand Name: Aptima®
Version or Model: KIT, TER, HBV, VL, 100T, US IVD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PRD-04081
Company Name: Hologic, Inc.

Primary DI Number: 15420045506770
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 050579217 *Terms of Use

Device Description: Aptima® HBV Quant Assay Target Enhancer Reagent.

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?
48219	HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of human immunodeficiency virus 1 (HIV1) nucleic acid, Hepatitis C virus nucleic acid, and Hepatitis B virus nucleic acid in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MKT	Hepatitis Viral B Dna Detection

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P170025	001
P170025	002
P170025	007
P170025	013
P170025	017

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: 76406bb6-a6b8-47bb-bdac-d4b8a5493454
Public Version Date: March 31, 2025
Public Version Number: 7
DI Record Publish Date: January 30, 2018