AccessGUDID - DEVICE: IMMCO DIAGNOSTICS (00845714001826)

GUDID

Device Identifier (DI) Information

Brand Name: IMMCO DIAGNOSTICS
Version or Model: 5118G
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5118G
Company Name: IMMCO DIAGNOSTICS, INC.

Primary DI Number: 00845714001826
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 079935300 *Terms of Use

Device Description: ACA IgG ELISA

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):	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 [?]
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
Device Size Text, specify: 96 determinations

Device Record Status

Public Device Record Key: 987e787d-6ac9-423e-97c9-25a8516f21fd
Public Version Date: August 16, 2022
Public Version Number: 3
DI Record Publish Date: September 21, 2016