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DSQ Alert BKV ASR v3.0 Probe Mix, 48 rxns

FDA UDI

Class I (US FDA UDI)

by ELITechGroup MDX LLC.

Identity

Trade Name
DSQ Alert BKV ASR v3.0 Probe Mix, 48 rxns FDA UDI
Generic Name
BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
DSQ Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligonucleotides designed to detect nucleic acids from the BK Virus. The mix consists of a total of 0.64 nmol of DSQ probe per vial in a 1X TE buffer solution. The probe is specific to a region of the major capsid protein VP1 gene of the BK Virus. The reagent contained in this package should be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles. FDA UDI
Model / Reference
M800727 FDA UDI
Description
DSQ Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligonucleotides designed to detect nucleic acids from the BK Virus. The mix consists of a total of 0.64 nmol of DSQ probe per vial in a 1X TE buffer solution. The probe is specific to a region of the major capsid protein VP1 gene of the BK Virus. The reagent contained in this package should be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles. FDA UDI

Identifiers

Primary DI / UDI-DI
03661540952753 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
BK virus (BKV) 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: BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)

DSQ Alert BKV ASR v3.0 Probe Mix, 48 rxns by ELITechGroup MDX LLC. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as BK virus (BKV) 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 c5a013a6-ec98-488d-99af-393a666e628e 35 fields · synced Jun 1, 2026