MGB Alert® CMV 3.0 Probe Mix ASR - 48 Reaction 800423

GUDID 03661540951541

"MGB Alert® CMV 3.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from CMV (Cytomegalovirus). The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm. "

ELITECH GROUP INC.

Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID03661540951541
NIH Device Record Key0713a756-3821-43f0-b6cd-19e3698374e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameMGB Alert® CMV 3.0 Probe Mix ASR - 48 Reaction
Version Model Number800423
Catalog Number800423
Company DUNS079696864
Company NameELITECH GROUP INC.
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

Phone8004532725
Emailmdx@elitechgroup.com
Phone8004532725
Emailmdx@elitechgroup.com
Phone8004532725
Emailmdx@elitechgroup.com
Phone8004532725
Emailmdx@elitechgroup.com
Phone8004532725
Emailmdx@elitechgroup.com
Phone8004532725
Emailmdx@elitechgroup.com
Phone8004532725
Emailmdx@elitechgroup.com
Phone8004532725
Emailmdx@elitechgroup.com
Phone8004532725
Emailmdx@elitechgroup.com
Phone8004532725
Emailmdx@elitechgroup.com
Phone8004532725
Emailmdx@elitechgroup.com
Phone8004532725
Emailmdx@elitechgroup.com
Phone8004532725
Emailmdx@elitechgroup.com
Phone8004532725
Emailmdx@elitechgroup.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS103661540951541 [Primary]
GS103661540951541 [Primary]
GS103661540951541 [Primary]
GS103661540951541 [Primary]
GS103661540951541 [Primary]
GS103661540951541 [Primary]
GS103661540951541 [Primary]
GS103661540951541 [Primary]
GS103661540951541 [Primary]
GS103661540951541 [Primary]
GS103661540951541 [Primary]
GS103661540951541 [Primary]
GS103661540951541 [Primary]
GS103661540951541 [Primary]

FDA Product Code

MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
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 Date2020-09-16
Device Publish Date2020-09-08

Devices Manufactured by ELITECH GROUP INC.

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03661540950124 - MGB Alert Internal Control Set IC2-B, 09N38-0012020-09-23 The MGB Alert Internal Control Set IC2-B consists of reagents intended for use as an unassayed internal extraction and amplifica
03661540950155 - MGB Alert Internal Control Set IC1, 09N39-0012020-09-23 The MGB Alert Internal Control Set IC1 consists of reagents intended for use as an unassayed internal extraction and amplificati
03661540950186 - MGB Alert Internal Control Set IC1-A, 09N40-0012020-09-23 The MGB Alert Internal Control Set IC1-A consists of reagents intended for use as an unassayed internal extraction and amplifica
03661540950247 - MGB Alert Internal Control Set IC2-T2020-09-23 The MGB Alert Internal Control Set IC2-T consists of reagents intended for use as an unassayed internal extraction and amplifica
03661540950254 - MGB Alert Internal Control Set IC2-T, 09N42-0012020-09-23 The MGB Alert Internal Control Set IC2-T consists of reagents intended for use as an unassayed internal extraction and amplifica
03661540950278 - MGB Alert Platinum Master Mix-48 rxn2020-09-23 The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays which target DNA analytes using re
03661540950322 - MGB Alert Internal Control Set IC2-8 48 rxn2020-09-23 The MGB Alert Internal Control Set IC2-8 consists of reagents intended for use as an unassayed internal extraction and amplifica

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