ImmunoFA 10x PBS 1006

GUDID 00613745010069

10-fold concentrate of 0.01M PBS

Genbio

Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, reagent
Primary Device ID00613745010069
NIH Device Record Key9dd1f795-9e37-4f5f-aa0b-a75fa0cf14fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameImmunoFA 10x PBS
Version Model Number800-1006
Catalog Number1006
Company DUNS940425333
Company NameGenbio
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone858-592-9300
Emailsupport@genbio.com
Phone858-592-9300
Emailsupport@genbio.com
Phone858-592-9300
Emailsupport@genbio.com

Device Dimensions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100613745010069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GLZAntigens, If, Toxoplasma Gondii

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 Date2016-09-24

On-Brand Devices [ImmunoFA 10x PBS]

0061374501006910-fold concentrate of 0.01M PBS
0061374501005210-fold concentrate of 0.01M PBS

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