AccessGUDID - DEVICE: E. coli O125abc serum high titer, 1 mL (05713106814383)

GUDID

Device Identifier (DI) Information

Brand Name: E. coli O125abc serum high titer, 1 mL
Version or Model: 81438
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 81438
Company Name: Ssi Diagnostica A/S

Primary DI Number: 05713106814383
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305684449 *Terms of Use

Device Description: Rabbit antiserum, High titer

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?
50950	Escherichia coli antigen 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 antigens from Escherichia coli (E. coli) bacteria in a clinical specimen and/or culture isolate.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GNA	ANTISERA, ALL TYPES, ESCHERICHIA COLI

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: 739af961-d01a-449d-aa6a-1592d5a4aae1
Public Version Date: August 19, 2021
Public Version Number: 1
DI Record Publish Date: August 11, 2021