AccessGUDID - DEVICE: ADVIA Centaur Zika IgM QC (00630414247014)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA Centaur Zika IgM QC
Version or Model: 11202472
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11202472
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414247014
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 Quality Control Material Kit 2 x 2 x 2.0 mL

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
QCH	Assayed quality control material for clinical microbiology assays

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9e06a97b-31dc-43e1-8c92-97168c982bc9
Public Version Date: November 18, 2021
Public Version Number: 3
DI Record Publish Date: February 24, 2020