← Back to catalogue

MDx-Chex for BC-GP

FDA UDI

Class II (US FDA UDI)

by Streck

Identity

Trade Name
MDx-Chex for BC-GP FDA UDI
Generic Name
Multiple-type bloodstream pathogen nucleic acid IVD, control FDA UDI
Device Name
MDx-Chex™ for BC-GP is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of Gram-positive bacteria and associated antimicrobial resistance genes, by the Luminex VERIGENE® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on Luminex VERIGENE® systems. The MDx-Chex™ for BC-GP Positive and Negative Controls are composed of a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components. Positive Control: Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Enterococcus faecalis, Enterococcus faecium, Streptococcus anginosus group; Species: Staphylococcus spp., Streptococcus spp., Listeria spp.; antimicrobial resistance genes: mecA, vanA and vanB. Negative Control: buffered solution only. This product is not intended to replace manufacturer controls provided with the device. FDA UDI
Model / Reference
250079 FDA UDI
Description
MDx-Chex™ for BC-GP is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of Gram-positive bacteria and associated antimicrobial resistance genes, by the Luminex VERIGENE® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on Luminex VERIGENE® systems. The MDx-Chex™ for BC-GP Positive and Negative Controls are composed of a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components. Positive Control: Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Enterococcus faecalis, Enterococcus faecium, Streptococcus anginosus group; Species: Staphylococcus spp., Streptococcus spp., Listeria spp.; antimicrobial resistance genes: mecA, vanA and vanB. Negative Control: buffered solution only. This product is not intended to replace manufacturer controls provided with the device. FDA UDI

Identifiers

Catalog Number
250079 FDA UDI
Primary DI / UDI-DI
00844509002468 FDA UDI
FDA Product Code
PMN FDA UDI
GMDN Term
Multiple-type bloodstream pathogen nucleic acid IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3920 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple-type bloodstream pathogen nucleic acid IVD, control

MDx-Chex for BC-GP by Streck — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-type bloodstream pathogen nucleic acid IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Streck

Sources (1)

  • FDA UDI 627324f4-a695-4931-b1a6-9884012595f6 34 fields · synced May 30, 2026