Henry Schein OneStep 1125547

GUDID 00304040001387

OneStep Pro Plus Mono

HENRY SCHEIN, INC.

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00304040001387
NIH Device Record Keyb48bb5e8-4419-4f9d-aadd-4a3df1121019
Commercial Distribution StatusIn Commercial Distribution
Brand NameHenry Schein OneStep
Version Model Number1125547
Catalog Number1125547
Company DUNS012430880
Company NameHENRY SCHEIN, 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 Producttrue
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100304040001387 [Primary]

FDA Product Code

KTNSYSTEM, TEST, INFECTIOUS MONONUCLEOSIS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-08
Device Publish Date2016-09-24

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