MGB Alert® Bordetella P/PP Primer Mix ASR - 48 Reactions 800437

GUDID 03661540951961

"MGB Alert® B. pertussis / B. parapertussis Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Bordetella pertussis and Bordetella parapertussis. The mix consists of a total of 6.0 nmol of primers per vial in a 1X TE buffer solution. The primers amplify insertion sequence IS481 in Bordetella pertussis and insertion sequence IS1001 in Bordetella parapertussis."

ELITECH GROUP INC.

Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT) Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT) Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT) Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT) Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT) Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT) Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT) Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT) Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT) Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT) Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT) Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT) Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT) Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID03661540951961
NIH Device Record Key616fc8a8-cd77-48ce-b99f-720e2d549792
Commercial Distribution StatusIn Commercial Distribution
Brand NameMGB Alert® Bordetella P/PP Primer Mix ASR - 48 Reactions
Version Model Number800437
Catalog Number800437
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
GS103661540951961 [Primary]
GS103661540951961 [Primary]
GS103661540951961 [Primary]
GS103661540951961 [Primary]
GS103661540951961 [Primary]
GS103661540951961 [Primary]
GS103661540951961 [Primary]
GS103661540951961 [Primary]
GS103661540951961 [Primary]
GS103661540951961 [Primary]
GS103661540951961 [Primary]
GS103661540951961 [Primary]
GS103661540951961 [Primary]
GS103661540951961 [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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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
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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
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