AccessGUDID - DEVICE: ZYM B (03573026141998)

GUDID

Device Identifier (DI) Information

Brand Name: ZYM B
Version or Model: 70493
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOMERIEUX SA

Primary DI Number: 03573026141998
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 276816717 *Terms of Use

Device Description: ZYM B is a reagent associated to API® Listeria (10 300), API® NH (10 400), API® Staph (20 500), API® 20 Strep (20 600), API® Coryne (20 900), API® ZYM (25 200)

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?
51656	Multiple Staphylococcus bacterial species culture isolate identification IVD, kit	A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of Staphylococcus bacteria or other similar gram positive, catalase positive cocci isolated by culture from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JTO	DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION

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: 34eb61be-0d72-4729-afc1-146d63fdf580
Public Version Date: April 10, 2024
Public Version Number: 2
DI Record Publish Date: April 10, 2020