AccessGUDID - DEVICE: Lysozyme (stool) ELISA (00840239061003)

GUDID

Device Identifier (DI) Information

Brand Name: Lysozyme (stool) ELISA
Version or Model: EIA-6100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EIA-6100
Company Name: DRG International Inc

Primary DI Number: 00840239061003
Issuing Agency: GS1
Commercial Distribution End Date: November 27, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 075150847 *Terms of Use

Device Description: This assay is an enzyme immunoassay intended for the quantitative determination of lysozyme in stool.

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):	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?
53119	Lysozyme (muramidase) 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 the bacteriolytic enzyme lysozyme (muramidase) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JMQ	M. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase)

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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fb277074-4f39-41dd-8efe-a157fbfa4a8b
Public Version Date: November 28, 2024
Public Version Number: 2
DI Record Publish Date: August 26, 2023