AccessGUDID - DEVICE: Elecsys HIV combi PT (04015630942497)

GUDID

Device Identifier (DI) Information

Brand Name: Elecsys HIV combi PT
Version or Model: 05390095160
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 05390095160
Company Name: Roche Diagnostics GmbH

Primary DI Number: 04015630942497
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315028860 *Terms of Use

Device Description: HIV combi PT Elecsys cobas e 100

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:	Yes
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?
48446	HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from and antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen, using an chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MZF	Test, Hiv Detection

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BP160050	0

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3d93edcc-65e8-4e48-b552-088b8be0dd82
Public Version Date: November 10, 2021
Public Version Number: 4
DI Record Publish Date: July 31, 2017