Lipase NG OC CTRL 2 04Y85-11

GUDID 08058056682314

Lipase NG OC CTRL 2 must be used only to verify the performance of the Lipase NG. Use the Control Material like the specimens, according to the indicated analytical procedure.

SENTINEL CH. SPA

Lipase IVD, control
Primary Device ID08058056682314
NIH Device Record Key828f844c-0d2d-432d-9f02-1fc50659e2c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameLipase NG OC CTRL 2
Version Model Number04Y85-11
Catalog Number04Y85-11
Company DUNS429572365
Company NameSENTINEL CH. SPA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9999999999
Emailcustomerservice@sentinel.it

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108058056682314 [Primary]

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-24
Device Publish Date2019-04-16

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