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MGB Alert Pneumocystis Probe Mix 48rxn,

FDA UDI

Class I (US FDA UDI)

by ELITechGroup MDX LLC.

Identity

Trade Name
MGB Alert Pneumocystis Probe Mix 48rxn, FDA UDI
Generic Name
Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
MGB Alert® Pneumocystis Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from Pneumocystis jirovecii. The mix consists of one probe at 0.56 nmol of probe per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm. FDA UDI
Model / Reference
M800572 FDA UDI
Description
MGB Alert® Pneumocystis Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from Pneumocystis jirovecii. The mix consists of one probe at 0.56 nmol of probe per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm. FDA UDI

Identifiers

Catalog Number
M800572 FDA UDI
Primary DI / UDI-DI
03661540950049 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Pneumocystis jirovecii 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: Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT)

MGB Alert Pneumocystis Probe Mix 48rxn, by ELITechGroup MDX LLC. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pneumocystis jirovecii 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 dba03870-f3d6-42c0-9c6b-aeabfb8f1814 36 fields · synced May 31, 2026