ANTI-TOXOPLASMA GONDII PU125-5UP

GUDID 00810119674425

BIOGENEX LABORATORIES

Toxoplasma gondii total antibody IVD, reagent
Primary Device ID00810119674425
NIH Device Record Key0e6f3b36-794a-4c2a-985b-84af2136016d
Commercial Distribution StatusIn Commercial Distribution
Brand NameANTI-TOXOPLASMA GONDII
Version Model NumberPU125-5UP
Catalog NumberPU125-5UP
Company DUNS042697045
Company NameBIOGENEX LABORATORIES
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 Usefalse
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

Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com

Device Dimensions

Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter
Total Volume0.5 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C

Device Identifiers

Device Issuing AgencyDevice ID
GS100810119674425 [Primary]

FDA Product Code

MVUReagents, Specific, Analyte

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-22
Device Publish Date2023-05-12

On-Brand Devices [ANTI-TOXOPLASMA GONDII]

00810119672964AR125-5R
00810119674425PU125-5UP

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