AccessGUDID - DEVICE: Echinococcus Antibody 96 Tests (00813545025380)

GUDID

Device Identifier (DI) Information

Brand Name: Echinococcus Antibody 96 Tests
Version or Model: EG-96
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EG-96
Company Name: SCIMEDX CORPORATION

Primary DI Number: 00813545025380
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 155424708 *Terms of Use

Device Description: No description.

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):	No
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?
52219	Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) 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 immunoglobulin G (IgG) antibodies to Echinococcus granulosus and/or Echinococcus multilocularis in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with the parasitic tapeworms associated with hydatid disease.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GPD	Antigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 83a2c335-ca42-4d52-87ab-e44064331c5e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 20, 2016