AccessGUDID - DEVICE: NG-Test CARBA 5 (03701077400133)

GUDID

Device Identifier (DI) Information

Brand Name: NG-Test CARBA 5
Version or Model: Kit of 20 tests for US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NGB-CAR-S23-018
Company Name: NG BIOTECH

Primary DI Number: 03701077400133
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 264235114 *Terms of Use

Device Description: Rapid test for the detection of carbapenemases KPC, OXA, VIM, IMP and NDM in a bacterial colony from culture.

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:	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?
43685	Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, kit	A collection of reagents and other associated materials intended to be used to determine the identification and antimicrobial susceptibility profile of bacterial species isolated from a clinical specimen by culture.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PTJ	Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191889	000

Device Exempt from Premarket Submission: No 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 4 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9c5d2de8-2e97-4ef9-a7b4-9c139aab5014
Public Version Date: June 20, 2025
Public Version Number: 3
DI Record Publish Date: December 02, 2019