NG-Test CARBA 5 NGB-CAR-S23-018

GUDID 03701077400133

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

NG BIOTECH

Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, kit

• Primary Device ID: 03701077400133
• NIH Device Record Key: 9c5d2de8-2e97-4ef9-a7b4-9c139aab5014
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NG-Test CARBA 5
• Version Model Number: Kit of 20 tests for US
• Catalog Number: NGB-CAR-S23-018
• Company DUNS: 264235114
• Company Name: NG BIOTECH
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +33223301783
• Email: contact@ngbiotech.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701077400133 [Primary]
GS1	03701077400140 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191889

FDA Product Code

• PTJ: Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-10
• Device Publish Date: 2019-12-02