Phoenix Biotech TS-960

GUDID 05391516747431

Trep-Sure™

CLARK LABORATORIES, INC.

Treponema pallidum total antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID05391516747431
NIH Device Record Key973cd839-9db4-4db6-94e1-df29681ee3aa
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhoenix Biotech
Version Model NumberTS-960
Catalog NumberTS-960
Company DUNS623214079
Company NameCLARK LABORATORIES, INC.
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 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

Phone1-800-325-3424
EmailCustomerservice@trinityusa.com

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105391516747431 [Primary]

FDA Product Code

LIPEnzyme Linked Immunoabsorption Assay, Treponema Pallidum

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-06
Device Publish Date2016-09-23

On-Brand Devices [Phoenix Biotech]

05391516747462Trep-Sure™
05391516747448Trep-Sure™
05391516747431Trep-Sure™
05391516747417Trep-Sure™
05391516747400Trep-Sure™
05391516747424Trep Sure Bulk Kit

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