AccessGUDID - DEVICE: ADVIA Centaur Zika IgM 50T (00630414247007)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA Centaur Zika IgM 50T
Version or Model: 11202471
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11202471
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414247007
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Zika IgM ADVIA Centaur Assay Kit 50T

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?
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
QFO	Zika virus serological reagents

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191578	000

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 64890d7f-3157-498f-b0d0-4650f1188677
Public Version Date: November 18, 2021
Public Version Number: 3
DI Record Publish Date: February 24, 2020