Zika ELITe MGB® - EUA M800552

GUDID 03661540950018

The United States (US) Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to authorize the use of the Zika ELITe MGB® Kit U.S. for the in vitro qualitative detection of Zika virus with specified instruments. This assay tests for Zika virus RNA in human serum and EDTA plasma.

ELITECH GROUP INC.

Zika virus nucleic acid IVD, kit, nucleic acid technique (NAT) Zika virus nucleic acid IVD, kit, nucleic acid technique (NAT) Zika virus nucleic acid IVD, kit, nucleic acid technique (NAT) Zika virus nucleic acid IVD, kit, nucleic acid technique (NAT) Zika virus nucleic acid IVD, kit, nucleic acid technique (NAT) Zika virus nucleic acid IVD, kit, nucleic acid technique (NAT) Zika virus nucleic acid IVD, kit, nucleic acid technique (NAT) Zika virus nucleic acid IVD, kit, nucleic acid technique (NAT) Zika virus nucleic acid IVD, kit, nucleic acid technique (NAT) Zika virus nucleic acid IVD, kit, nucleic acid technique (NAT) Zika virus nucleic acid IVD, kit, nucleic acid technique (NAT) Zika virus nucleic acid IVD, kit, nucleic acid technique (NAT) Zika virus nucleic acid IVD, kit, nucleic acid technique (NAT) Zika virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID03661540950018
NIH Device Record Keya69bb12c-33eb-4c0c-a5b5-df4520ac332c
Commercial Distribution StatusIn Commercial Distribution
Brand NameZika ELITe MGB® - EUA
Version Model NumberM800552
Catalog NumberM800552
Company DUNS079696864
Company NameELITECH GROUP INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptiontrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS103661540950018 [Primary]
GS103661540950018 [Primary]
GS103661540950018 [Primary]
GS103661540950018 [Primary]
GS103661540950018 [Primary]
GS103661540950018 [Primary]
GS103661540950018 [Primary]
GS103661540950018 [Primary]
GS103661540950018 [Primary]
GS103661540950018 [Primary]
GS103661540950018 [Primary]
GS103661540950018 [Primary]
GS103661540950018 [Primary]
GS103661540950018 [Primary]

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.

03661540950032 - MGB Alert Internal Control Set IC2-BH 48 rxn2020-09-23 The MGB Alert Internal Control Set IC2-BH consists of reagents intended for use as an unassayed internal extraction and amplific
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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