MGB Alert® Chlamydophila Pneumoniae Probe Mix ASR - 48 Reactions 800434

GUDID 03661540951770

MGB Alert® Chlamydophila pneumoniae Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect the Major Outer Membrane protein gene region of Chlamydophila pneumoniae. The mix consists of one probe at 0.72 nmol per vial in a 1X TE buffer solution. The probe is labeled with fluorescein (FAM) and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm.

ELITECH GROUP INC.

Chlamydia pneumoniae nucleic acid IVD, kit, nucleic acid technique (NAT) Chlamydia pneumoniae nucleic acid IVD, kit, nucleic acid technique (NAT) Chlamydia pneumoniae nucleic acid IVD, kit, nucleic acid technique (NAT) Chlamydia pneumoniae nucleic acid IVD, kit, nucleic acid technique (NAT) Chlamydia pneumoniae nucleic acid IVD, kit, nucleic acid technique (NAT) Chlamydia pneumoniae nucleic acid IVD, kit, nucleic acid technique (NAT) Chlamydia pneumoniae nucleic acid IVD, kit, nucleic acid technique (NAT) Chlamydia pneumoniae nucleic acid IVD, kit, nucleic acid technique (NAT) Chlamydia pneumoniae nucleic acid IVD, kit, nucleic acid technique (NAT) Chlamydia pneumoniae nucleic acid IVD, kit, nucleic acid technique (NAT) Chlamydia pneumoniae nucleic acid IVD, kit, nucleic acid technique (NAT) Chlamydia pneumoniae nucleic acid IVD, kit, nucleic acid technique (NAT) Chlamydia pneumoniae nucleic acid IVD, kit, nucleic acid technique (NAT) Chlamydia pneumoniae nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID03661540951770
NIH Device Record Keye68235f0-0faf-4bb5-9cfe-57dee002f15c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMGB Alert® Chlamydophila Pneumoniae Probe Mix ASR - 48 Reactions
Version Model Number800434
Catalog Number800434
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
GS103661540951770 [Primary]
GS103661540951770 [Primary]
GS103661540951770 [Primary]
GS103661540951770 [Primary]
GS103661540951770 [Primary]
GS103661540951770 [Primary]
GS103661540951770 [Primary]
GS103661540951770 [Primary]
GS103661540951770 [Primary]
GS103661540951770 [Primary]
GS103661540951770 [Primary]
GS103661540951770 [Primary]
GS103661540951770 [Primary]
GS103661540951770 [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

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03661540950018 - Zika ELITe MGB® - EUA2020-09-16 The United States (US) Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to authorize the use o

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