AccessGUDID - DEVICE: ELISA Cardiolipin IgG Smart Kit Test System (00845533000314)

GUDID

Device Identifier (DI) Information

Brand Name: ELISA Cardiolipin IgG Smart Kit Test System
Version or Model: SM2Z51051G
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SM2Z51051G
Company Name: ZEUS SCIENTIFIC, INC.

Primary DI Number: 00845533000314
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080953946 *Terms of Use

Device Description: The ZEUS ELISA Cardiolipin IgG Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgG autoantibodies to cardiolipin.

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?
54870	Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple classes of antibodies to cardiolipin in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	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: 445e6ac6-c895-429d-868c-ec721a703827
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016