Lipase NG OC Cal 04Y85-01

GUDID 08058056682291

Lipase NG OC Cal must be used only for the calibration of Lipase NG. For In Vitro Diagnostic use.

SENTINEL CH. SPA

Lipase IVD, calibrator
Primary Device ID08058056682291
NIH Device Record Keybc01996a-853c-484c-8e7a-dfb4c70e7900
Commercial Distribution StatusIn Commercial Distribution
Brand NameLipase NG OC Cal
Version Model Number04Y85-01
Catalog Number04Y85-01
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
GS108058056682291 [Primary]

FDA Product Code

JITCalibrator, Secondary

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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