AccessGUDID - DEVICE: Sensititre GP Panel PLATE DRY CLI GRAM+ ID AUTO (00848838074363)

GUDID

Device Identifier (DI) Information

Brand Name: Sensititre GP Panel PLATE DRY CLI GRAM+ ID AUTO
Version or Model: GPID
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: REMEL, INC.

Primary DI Number: 00848838074363
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 065769564 *Terms of Use

Device Description: PLATE DRY CLI GRAM+ ID AUTO A semi-quantitative test intended for the automated identification of Gram positive bacterial isolates based on biochemical reactions. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, the device requires an automated system to produce a result and requires a pure, agar grown culture. This device is for professional use only and is not a companion diagnostic.

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):	Yes
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?
50419	Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit	A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of aerobic gram positive bacteria that have been isolated by culture from a clinical specimen. Bacteria which may be identified typically belong to the genera Staphylococcus, Enterococcus, or may represent other gram positive cocci and gram positive bacilli genera.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LQL	Gram Positive Identification Panel

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5283b48e-7ec1-443c-b89d-4076081476a6
Public Version Date: June 28, 2023
Public Version Number: 1
DI Record Publish Date: June 20, 2023