AccessGUDID - DEVICE: Microbiology Slides (10845357043471)

GUDID

Device Identifier (DI) Information

Brand Name: Microbiology Slides
Version or Model: SL90-05
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SL90-05
Company Name: MICROBIOLOGICS INC.

Primary DI Number: 10845357043471
Issuing Agency: GS1
Commercial Distribution End Date: December 17, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 060467826 *Terms of Use

Device Description: Microbiology Slides Blood Parasite Control Slide

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?
47360	Multiple faecal parasite 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 one or multiple faecal parasite antigens (e.g., Giardia, Entamoeba and Cryptosporidium species) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LJG	QUALITY CONTROL SLIDES

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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bd431c82-5bec-4403-8e15-c54fe181c933
Public Version Date: December 25, 2020
Public Version Number: 1
DI Record Publish Date: December 17, 2020