AccessGUDID - DEVICE: Phadebact CSF Positive Controls (07350049850238)

GUDID

Device Identifier (DI) Information

Brand Name: Phadebact CSF Positive Controls
Version or Model: 10-5593-12
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Mkl Diagnostics AB

Primary DI Number: 07350049850238
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 350472667 *Terms of Use

Device Description: No description.

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):	Yes
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?
50401	Multiple meningitis-associated bacteria antigen IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple bacteria associated with meningitis, in a clinical specimen. Bacteria detected may include Haemophilus influenzae, Streptococcus pneumoniae, Neisseria meningitidis, Group B streptococcus or Escherichia coli (E. coli) bacteria.	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: 54da30d5-9cfd-40b5-8769-6b879a1ac1b4
Public Version Date: September 20, 2018
Public Version Number: 1
DI Record Publish Date: August 20, 2018