AccessGUDID - DEVICE: ADVIA Centaur® Zika IgM Assay 50T (00630414170862)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA Centaur® Zika IgM Assay 50T
Version or Model: 11200103
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 11200103
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414170862
Issuing Agency: GS1
Commercial Distribution End Date: November 05, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: ADVIA Centaur® Zika IgM Assay

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?
49107	Zika virus immunoglobulin M (IgM) 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 immunoglobulin M (IgM) antibodies to Zika virus in a clinical specimen, using a chemiluminescent immunoassay method.	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Handling Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: keep out of direct sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 38b0bb03-cd03-4791-9a89-d011de1bc4d3
Public Version Date: November 18, 2021
Public Version Number: 4
DI Record Publish Date: December 26, 2018