AccessGUDID - DEVICE: QMedix™ (00850054026477)

GUDID

Device Identifier (DI) Information

Brand Name: QMedix™
Version or Model: DACD1801-18
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1801-18
Company Name: Diagnostic Automation, Inc.

Primary DI Number: 00850054026477
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878252071 *Terms of Use

Device Description: QMedix™Total Human IgE ELISA This test is intended to be used for the qualitative and/or quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergen(s) in a clinical specimen, using an enzyme immunoassay (EIA) method.

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?
58946	Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergens and total immunoglobulin E (IgE total) antibodies in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DGC	Ige, Antigen, Antiserum, Control

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 Tests

Device Record Status

Public Device Record Key: c7279069-106a-4840-9ce3-c8fc6104ef8b
Public Version Date: February 08, 2024
Public Version Number: 1
DI Record Publish Date: January 31, 2024