AmpliVue M212

GUDID 30014613312123

AmpliVue GAS Assay

QUIDEL CORPORATION

Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID30014613312123
NIH Device Record Keyc274905a-e456-4fc3-8c58-6948350a94fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmpliVue
Version Model NumberGroup A Strep Assay
Catalog NumberM212
Company DUNS079509836
Company NameQUIDEL CORPORATION
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS130014613312123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PGXGroups A, C and G beta-hemolytic streptococcus nucleic acid amplification system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-15

On-Brand Devices [AmpliVue]

30014613312123AmpliVue GAS Assay
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30014613312109AmpliVue HSV 1+2 Assay
30014613312093AmpliVue Bordetella Assay
30014613312024AmpliVue GBS Assay
30014613312017AmpliVue CDiff Assay

Trademark Results [AmpliVue]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AMPLIVUE
AMPLIVUE
85140233 4147342 Live/Registered
Quidel Corporation
2010-09-28

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