AccessGUDID - DEVICE: Vista COV2T Assay (00630414605500)

GUDID

Device Identifier (DI) Information

Brand Name: Vista COV2T Assay
Version or Model: 11417414
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: K7414
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414605500
Issuing Agency: GS1
Commercial Distribution End Date: September 01, 2023
Device Count: 4
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Vista COV2T 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:	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?
64865	SARS-CoV-2 total 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 total antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a chemiluminescent immunoassay method. This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QKO	Reagent, coronavirus serological

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: Store Upright

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dfe4dd50-7038-450c-ae78-172d4ff6b91d
Public Version Date: December 08, 2023
Public Version Number: 3
DI Record Publish Date: August 09, 2021