AccessGUDID - DEVICE: AtheNA Multi-Lyte® ANA-II Plus Test System (00845533000017)

GUDID

Device Identifier (DI) Information

Brand Name: AtheNA Multi-Lyte® ANA-II Plus Test System
Version or Model: A21101
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A21101
Company Name: ZEUS SCIENTIFIC, INC.

Primary DI Number: 00845533000017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080953946 *Terms of Use

Device Description: The ZEUS AtheNA Multi-Lyte® ANA-II Plus Test System is intended for the semi-quantitative detection of IgG class antibody to eight separate analytes (SSA, SSB, Sm, RNP, Scl-70, Jo-1, Centromere B, and Histone) in human serum, the quantitative detection of IgG class antibody to dsDNA in human serum, and the qualitative detection of IgG class antibody to ANA. The test system is intended to be used as an aid in the diagnosis of various systemic autoimmune disorders. This test is for In Vitro diagnostic use.

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
54810	Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for multiple types of antinuclear antibodies (ANA) in a clinical specimen, using a multiplex method.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

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

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
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: 54548422-74c9-4de4-86c8-f6eb4553ef20
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016