FDA.reportPublic FDA data

NG-TEST CTX-M Multi

Primary DI
03701077402274
Brand
NG-TEST CTX-M Multi
Company
NG BIOTECH
Model
Kit of 20 tests for US
Catalog number
NGB-CTM-S23-018
Device description
Rapid test for the detection of CTX-M enzymes (groups 1, 2, 8, 9, and 25) in a bacterial colony from culture.
Published
2025-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PTJPhenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTJPhenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured IsolatesMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243499000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243499000NG-Test® CTX-M MULTINg Biotech2025-06-04PTJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701077402274PrimaryGS10
03701077402359Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701077402274037010774022743701077402274
03701077402359037010774023593701077402359

GMDN Terms#

Term, Definition table
TermDefinition
Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, kitA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33223301783support@ngbiotech.com

Regulatory Flags#

DUNS number
264235114
Device count
20
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701077400133NG-Test CARBA 5Kit of 20 tests for USNGB-CAR-S23-0182019-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701077400133NG-Test CARBA 5NG BIOTECHPTJ2019-12-02
03573026464370RAPIDEC® CARBA NPBIOMERIEUX SAPTJ2017-07-04
03573026464387RAPIDEC® CARBA NPBIOMERIEUX SAPTJ2017-07-04