AccessGUDID - DEVICE: Poly Rb A-Hu Lysozyme EC 3.2.1.17 (05700572000686)

GUDID

Device Identifier (DI) Information

Brand Name: Poly Rb A-Hu Lysozyme EC 3.2.1.17
Version or Model: A0099
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AGILENT TECHNOLOGIES SINGAPORE PTE LTD

Primary DI Number: 05700572000686
Issuing Agency: GS1
Commercial Distribution End Date: May 08, 2029
Device Count: 1
Labeler D-U-N-S® Number*: 894671143 *Terms of Use

Device Description: Polyclonal Rabbit Anti-Human Lysozyme EC 3.2.1.17

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):	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?
57364	Lysozyme (muramidase) IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of the bacteriolytic enzyme lysozyme (muramidase) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JMR	IMMUNOCHEMICAL, 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
Total Volume: 2 Milliliter

Device Record Status

Public Device Record Key: 060f3dd3-eeaf-4104-b78b-0ca214536403
Public Version Date: August 02, 2024
Public Version Number: 3
DI Record Publish Date: September 17, 2020