AccessGUDID - DEVICE: ImmuLex Pneumococcus Pool E serum, 1.5 mL (05713106523940)

GUDID

Device Identifier (DI) Information

Brand Name: ImmuLex Pneumococcus Pool E serum, 1.5 mL
Version or Model: 52394
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 52394
Company Name: Ssi Diagnostica A/S

Primary DI Number: 05713106523940
Issuing Agency: GS1
Commercial Distribution End Date:
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?
51772	Streptococcus pneumoniae culture isolate 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 Streptococcus pneumoniae bacteria isolated by culture from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWC	ANTISERA, ALL TYPES, STREPTOCOCCUS PNEUMONIAE

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: bb5ac216-77ca-44db-b463-59d10869f00c
Public Version Date: August 02, 2021
Public Version Number: 1
DI Record Publish Date: July 25, 2021