AccessGUDID - DEVICE: E. Histolytica IgG ELISA (00840239034748)

GUDID

Device Identifier (DI) Information

Brand Name: E. Histolytica IgG ELISA
Version or Model: EIA-3474
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EIA-3474
Company Name: DRG International Inc

Primary DI Number: 00840239034748
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 075150847 *Terms of Use

Device Description: The E. histolytica ELISA test is a qualitative enzyme immunoassay for the detection of antibodies to E. histolytica, in samples of 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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
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?
52225	Entamoeba histolytica 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 Entamoeba histolytica in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Entamoeba histolytica, the parasitic protozoan associated with amoebiasis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KHW	ANTIGEN, ID, HA, CEP, ENTAMOEBA HISTOLYTICA & REL. SPP.

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
Device Size Text, specify: Positive Control
Device Size Text, specify: Stop Solution
Device Size Text, specify: Chromogen TMB
Total Volume: 11 Milliliter
Total Volume: 1 Milliliter
Total Volume: 30 Milliliter
Device Size Text, specify: Enzyme Conjugate
Total Volume: 25 Milliliter
Device Size Text, specify: Negative Control
Device Size Text, specify: Wash Concentrate
Device Size Text, specify: Dilution Buffer

Device Record Status

Public Device Record Key: 927a36a2-859d-4ccb-908c-9d3e267c8b7b
Public Version Date: March 30, 2020
Public Version Number: 2
DI Record Publish Date: March 20, 2019