ImmunoFA Toxoplasma Slides 1207

GUDID 00613745012070

For use with ImmunoFA Toxoplasma kits

Genbio

Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, reagent
Primary Device ID00613745012070
NIH Device Record Key7ffd074c-f6b7-4714-bfe3-cad90c5f49b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameImmunoFA Toxoplasma Slides
Version Model Number800-1207
Catalog Number1207
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 -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613745012070 [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 Toxoplasma Slides]

00613745012070For use with ImmunoFA Toxoplasma kits
00613745012018Toxoplasma Slides for use with ImmunoFA Toxoplasma kits

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