Platelia 12015289

GUDID 03610522220519

Platelia SARS-CoV-2 Total Ab

BIO-RAD

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Primary Device ID03610522220519
NIH Device Record Key1ffde3c0-a900-4f77-85bc-de7e859ffa13
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlatelia
Version Model Number12015289
Catalog Number12015289
Company DUNS269902602
Company NameBIO-RAD
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)224-6723
Emailtechsupport.ussd-redmond@bio-rad.com
Phone+1(800)224-6723
Emailtechsupport.ussd-redmond@bio-rad.com
Phone+1(800)224-6723
Emailtechsupport.ussd-redmond@bio-rad.com
Phone+1(800)224-6723
Emailtechsupport.ussd-redmond@bio-rad.com
Phone+1(800)224-6723
Emailtechsupport.ussd-redmond@bio-rad.com
Phone+1(800)224-6723
Emailtechsupport.ussd-redmond@bio-rad.com
Phone+1(800)224-6723
Emailtechsupport.ussd-redmond@bio-rad.com
Phone+1(800)224-6723
Emailtechsupport.ussd-redmond@bio-rad.com
Phone+1(800)224-6723
Emailtechsupport.ussd-redmond@bio-rad.com
Phone+1(800)224-6723
Emailtechsupport.ussd-redmond@bio-rad.com
Phone+1(800)224-6723
Emailtechsupport.ussd-redmond@bio-rad.com
Phone+1(800)224-6723
Emailtechsupport.ussd-redmond@bio-rad.com
Phone+1(800)224-6723
Emailtechsupport.ussd-redmond@bio-rad.com
Phone+1(800)224-6723
Emailtechsupport.ussd-redmond@bio-rad.com
Phone+1(800)224-6723
Emailtechsupport.ussd-redmond@bio-rad.com
Phone+1(800)224-6723
Emailtechsupport.ussd-redmond@bio-rad.com
Phone+1(800)224-6723
Emailtechsupport.ussd-redmond@bio-rad.com

Device Dimensions

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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

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

Device Identifiers

Device Issuing AgencyDevice ID
GS103610522220519 [Primary]

FDA Product Code

QKOReagent, coronavirus serological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-11
Device Publish Date2023-07-03

On-Brand Devices [Platelia]

03610522220526Platelia SARS-CoV-2 Total Ab
03610522220519Platelia SARS-CoV-2 Total Ab
03610520007877PLATELIA Lyme IgG
03610520007860PLATELIA Lyme IgM

Trademark Results [Platelia]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PLATELIA
PLATELIA
87904500 5627797 Live/Registered
Bio-Rad Laboratories SAS
2018-05-02
PLATELIA
PLATELIA
79009937 3181095 Live/Registered
Bio-Rad Laboratories SAS
2005-03-10

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