Trinity Biotech

GUDID 05391516746519

Wash Buffer Concentrate Type I, 20X

CLARK LABORATORIES, INC.

Buffered wash solution IVD, manual
Primary Device ID05391516746519
NIH Device Record Key34530c8e-0aee-4eb6-8ab9-794a8799e47f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrinity Biotech
Version Model Number827102
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 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

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

Device Dimensions

Total Volume50 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105391516746519 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFXEnzyme Linked Immunoabsorbent Assay, Rubella

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-06
Device Publish Date2019-12-27

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