AccessGUDID - DEVICE: Candida albicans IgG ELISA (00840239034588)

GUDID

Device Identifier (DI) Information

Brand Name: Candida albicans IgG ELISA
Version or Model: EIA-3458
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EIA-3458
Company Name: DRG International Inc

Primary DI Number: 00840239034588
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 075150847 *Terms of Use

Device Description: The DRG Candida albicans IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Candida albicans in serum.

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?
52056	Candida albicans 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 the yeast Candida albicans in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LSG	CANDIDA SPECIES, ANTIBODY DETECTION

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: Stop Solution
Total Volume: 30 Milliliter
Device Size Text, specify: Wash Solution
Device Size Text, specify: Enzyme Conjugate
Device Size Text, specify: Sample Diluent
Total Volume: 14 Milliliter
Total Volume: 20 Milliliter
Device Size Text, specify: Substrate Solution
Device Size Text, specify: Positive Control
Device Size Text, specify: Negative Control
Device Size Text, specify: Cut-off Control
Total Volume: 2 Milliliter
Total Volume: 100 Milliliter

Device Record Status

Public Device Record Key: b2a9192c-9188-4a25-900c-8e1ab71f5b1e
Public Version Date: March 30, 2020
Public Version Number: 2
DI Record Publish Date: March 20, 2019