AccessGUDID - DEVICE: ADVIA Centaur® EHIV (00630414511245)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA Centaur® EHIV
Version or Model: 10332613
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1622429
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414511245
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: HIV 1/O/2 Enhanced (EHIV) (1-pack) 200T Assay 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:	Yes
Prescription Use (Rx):	No
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?
48452	HIV1/HIV2 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 antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen, using a 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 [?]
BP050030	0
BP050030	10
BP050030	13
BP050030	21
BP050030	5
BP050030	8

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
Special Storage Condition, Specify: Store Upright, Protect from Light, Do not freeze, Resuspend.
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8da79ab4-7df4-4f94-b980-dadf532133d2
Public Version Date: July 29, 2022
Public Version Number: 7
DI Record Publish Date: September 24, 2014