AccessGUDID - DEVICE: IMMCO DIAGNOSTICS (00845714000768)

GUDID

Device Identifier (DI) Information

Brand Name: IMMCO DIAGNOSTICS
Version or Model: 1114A-PDE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1114A-PDE
Company Name: IMMCO DIAGNOSTICS, INC.

Primary DI Number: 00845714000768
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079935300 *Terms of Use

Device Description: Anti-Endomysial Antibody (EMA) IFA Kit

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?
54905	Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-endomysial antibodies (anti-EMA) in a clinical specimen, using a fluorescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)

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: 48 DETERMINATIONS

Device Record Status

Public Device Record Key: 83bacb4b-4176-4934-b3fa-ee359b674830
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 21, 2016