AccessGUDID - DEVICE: SARS-CoV-2 IgM AccuBind ELISA Test System

GUDID

Device Identifier (DI) Information

Brand Name: SARS-CoV-2 IgM AccuBind ELISA Test System - 192 Wells
Version or Model: 11725-300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11725-300B
Company Name: MONOBIND, INC.

Primary DI Number: 00816870023649
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083155515 *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:	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?
64800	SARS-CoV-2 immunoglobulin M (IgM) 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 M (IgM) antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using an enzyme immunoassay (EIA) method. This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QKO	Reagent, coronavirus serological

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
Width: 7.75 Inch

Device Record Status

Public Device Record Key: 54202eaf-b3a7-4ec5-8994-faa955499b79
Public Version Date: September 23, 2024
Public Version Number: 1
DI Record Publish Date: September 13, 2024