AccessGUDID - DEVICE: ADVIA Centaur® Zika Ab Quality Control (00842768025273)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA Centaur® Zika Ab Quality Control
Version or Model: 11200712
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 11200712
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768025273
Issuing Agency: GS1
Commercial Distribution End Date: July 31, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: ADVIA Centaur Zika Test - Zika Ab Controls

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):	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?
49109	Zika virus immunoglobulin M (IgM) antibody 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 immunoglobulin M (IgM) antibodies to Zika virus in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PYS	Zika virus Serological Reagents

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Handling Environment Temperature: between 2 and 8 Degrees Celsius
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: 5bce65c6-f470-44ce-b399-bed4f99c7eda
Public Version Date: November 18, 2021
Public Version Number: 4
DI Record Publish Date: December 26, 2018