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DSQ Alert HT Candida auris Probe Mix ASR, 192 rxn Final Assembly

FDA UDI

Class I (US FDA UDI)

by ELITechGroup MDX LLC.

Identity

Trade Name
DSQ Alert HT Candida auris Probe Mix ASR, 192 rxn Final Assembly FDA UDI
Generic Name
Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
DSQ Alert™ HT Candida auris Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the ITS2 gene of Candida auris. The mix consists of a total of 3.9 nmol of probe per vial in a 1X TE buffer solution. The probe is labeled with FAM and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm. FDA UDI
Model / Reference
M800761 FDA UDI
Description
DSQ Alert™ HT Candida auris Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the ITS2 gene of Candida auris. The mix consists of a total of 3.9 nmol of probe per vial in a 1X TE buffer solution. The probe is labeled with FAM and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm. FDA UDI

Identifiers

Primary DI / UDI-DI
03661540952579 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Candida auris 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: Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT)

DSQ Alert HT Candida auris Probe Mix ASR, 192 rxn Final Assembly by ELITechGroup MDX LLC. — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Candida auris 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 465136e3-f25f-42fb-a201-ba669a5ace39 35 fields · synced Jun 1, 2026