AccessGUDID - DEVICE: ImmuLex Streptococcus Group F, 1.5 mL (05713106732625)

GUDID

Device Identifier (DI) Information

Brand Name: ImmuLex Streptococcus Group F, 1.5 mL
Version or Model: 73262
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 73262
Company Name: Ssi Diagnostica A/S

Primary DI Number: 05713106732625
Issuing Agency: GS1
Commercial Distribution End Date: August 03, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 305684449 *Terms of Use

Device Description: Rabbit antiserum, Ready to use

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:	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?
63135	Multiple Streptococcus species antigen IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative detection of antigens from multiple species of Streptococcus bacteria in a clinical specimen and/or culture isolate.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GTZ	ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.

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: 2eb75319-00c3-4333-9355-f521d696ba24
Public Version Date: September 15, 2023
Public Version Number: 2
DI Record Publish Date: August 01, 2021