AccessGUDID - DEVICE: Anti-Cardiolipin IgA ELISA (00840239035882)

GUDID

Device Identifier (DI) Information

Brand Name: Anti-Cardiolipin IgA ELISA
Version or Model: EIA-3588
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EIA-3588
Company Name: DRG International Inc

Primary DI Number: 00840239035882
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 075150847 *Terms of Use

Device Description: Anti-Cardiolipin IgA ELISA is a test system for the quantitative measurement of IgA class autoantibodies against cardiolipin in human serum or plasma

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
MID	System, Test, Anticardiolipin Immunological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K962469	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
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: 28f679d0-02a5-49e9-8acc-3aba245a2398
Public Version Date: September 04, 2023
Public Version Number: 1
DI Record Publish Date: August 25, 2023