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Gram-Positive Blood Culture (BC-GP) Extraction Tray

FDA UDI

Class II (US FDA UDI)

by Luminex Corporation

Identity

Trade Name
Gram-Positive Blood Culture (BC-GP) Extraction Tray FDA UDI
Generic Name
Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
The Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene® System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). FDA UDI
Model / Reference
20-009-018 FDA UDI
Description
The Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene® System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). FDA UDI

Identifiers

Catalog Number
20-009-018 FDA UDI
Primary DI / UDI-DI
00840487101629 FDA UDI
FDA Product Code
PAM FDA UDI
NQX FDA UDI
GMDN Term
Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3365 FDA UDI
866.1640 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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, kit, nucleic acid technique (NAT)

Gram-Positive Blood Culture (BC-GP) Extraction Tray by Luminex Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Luminex Corporation

Sources (1)

  • FDA UDI 65157773-37a8-4522-95e5-9e2a1dde5289 36 fields · synced Jun 9, 2026