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

GUDID 03661540952753

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.

Elitechgroup Mdx LLC

BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID03661540952753
NIH Device Record Keyc5a013a6-ec98-488d-99af-393a666e628e
Commercial Distribution StatusIn Commercial Distribution
Brand NameDSQ Alert BKV ASR v3.0 Probe Mix, 48 rxns
Version Model NumberM800727
Company DUNS117458512
Company NameElitechgroup Mdx LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com
Phone1-833-227-3400
Emailmdx@elitechgroup.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103661540952753 [Primary]

FDA Product Code

MVUReagents, Specific, Analyte

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-23
Device Publish Date2024-05-15

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