AccessGUDID - DEVICE: APTIMA® (15420045504233)

GUDID

Device Identifier (DI) Information

Brand Name: APTIMA®
Version or Model: KIT, CONTROLS, HIV QUANT, US IVD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PRD-03567
Company Name: Hologic, Inc.

Primary DI Number: 15420045504233
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 050579217 *Terms of Use

Device Description: Aptima® HIV-1 Quant Dx Assay Controls 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?
48466	HIV1 nucleic acid IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of human immunodeficiency virus 1 (HIV1) nucleic acid in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MZF	Test, hiv detection

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BP150318	002
BP150318	004
BP150318	005
BP150318	006
BP150318	007
BP150318	008
BP150318	009
BP150318	012
BP150318	013
BP150318	014
BP150318	015
BP150318	016
BP150318	018
BP150318	020
BP150318	021
BP150318	026
BP150318	027
BP150318	028

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: d7d66883-562d-4910-91c6-465e534dacb5
Public Version Date: June 06, 2024
Public Version Number: 5
DI Record Publish Date: January 18, 2017