FDA.reportPublic FDA data

MGB Alert® BKV Probe Mix ASR - 480 Reactions QTY-100

Primary DI
03661540952180
Brand
MGB Alert® BKV Probe Mix ASR - 480 Reactions QTY-100
Company
ELITECH GROUP INC.
Model
800333-100
Catalog number
800333-100
Device description
MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from BK Virus. The mix consists of one probe at 1.5 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm. QTY 100 vials @ 480 reactions each.
Published
2022-04-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVUReagents, Specific, Analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661540952180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540952180036615409521803661540952180

GMDN Terms#

Term, Definition table
TermDefinition
BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from BK virus (BKV) in a clinical specimen, using a nucleic acid technique (NAT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-10 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8004532725mdx@elitechgroup.com

Regulatory Flags#

DUNS number
079696864
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661540952371MGB Alert IC1 Internal Control Template (35uL volume)M8007352022-07-05
03661540952258MGB Alert Internal Control Set IC2-B, 480 rxn QTY-25800363-25800363-252022-04-04
03661540952265MGB Alert Internal Control Set IC2-B, 480 rxn QTY-100800363-100800363-1002022-04-04
03661540952296 MGB Alert Internal Control Set IC2-C -480 rxn QTY-25800432-25800432-252022-04-04
03661540952302 MGB Alert Internal Control Set IC2-C -480 rxn QTY-100800432-100800432-1002022-04-04
03661540952173MGB Alert® BKV Primer Mix ASR - 480 Reactions QTY 100800332-100800332-1002022-04-04
03661540952197MGB Alert® CMV 3.0 Primer Mix ASR - 480 Reactions QTY-25 800350-25800350-252022-04-04
03661540952203MGB Alert® CMV 3.0 Primer Mix ASR - 480 Reactions QTY-100800350-100800350-1002022-04-04
03661540952210MGB Alert® CMV 3.0 Probe Mix ASR - 480 Reactions QTY-25800404-25800404-252022-04-04
03661540952227MGB Alert® CMV 3.0 Probe Mix ASR - 480 Reactions QTY-100800404-100800404-1002022-04-04
03661540952272MGB Alert® BKV Primer Mix ASR - 480 Reactions QTY 25800332-25800332-252022-04-04
03661540952289MGB Alert® BKV Probe Mix ASR - 480 Reactions QTY-25800333-25800333-252022-04-04

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