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MGB Alert® Pan Legionella Probe Mix ASR - 48 Reactions

FDA UDI

Class I (US FDA UDI)

by ELITechGroup MDX LLC.

Identity

Trade Name
MGB Alert® Pan Legionella Probe Mix ASR - 48 Reactions FDA UDI
Generic Name
Legionella species nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
"MGB Alert® Pan Legionella Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the ssrA gene region of Legionella micdadei. The mix consists of one probe at 1.44 nmol per vial in a 1X TE buffer solution. The probe is labeled with AP525 and has an excitation wavelength maxima of 527 nm and an emission wavelength maxima of 549 nm" FDA UDI
Model / Reference
M800687 FDA UDI
Description
"MGB Alert® Pan Legionella Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the ssrA gene region of Legionella micdadei. The mix consists of one probe at 1.44 nmol per vial in a 1X TE buffer solution. The probe is labeled with AP525 and has an excitation wavelength maxima of 527 nm and an emission wavelength maxima of 549 nm" FDA UDI

Identifiers

Catalog Number
M800687 FDA UDI
Primary DI / UDI-DI
03661540951220 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Legionella species nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4020 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

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Legionella species nucleic acid IVD, kit, nucleic acid technique (NAT)

MGB Alert® Pan Legionella Probe Mix ASR - 48 Reactions by ELITechGroup MDX LLC. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Legionella species 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
ELITechGroup MDX LLC.

Sources (1)

  • FDA UDI 3e1920e2-b32b-44e3-8850-b25d7d9f39ee 36 fields · synced Jun 8, 2026