Immuno Control Set 11211A

GUDID 08058056680204

Immuno Control Set is for use in quality control by monitoring accuracy and precision for the quantitative method as specified in the assigned concentration Table. Use the Control Material like the specimens, according to the indicated analytical procedure. For professional use only. For In Vitro diagnostic use.

SENTINEL CH. SPA

Plasma protein IVD, control
Primary Device ID08058056680204
NIH Device Record Keye84862e8-f8d8-4165-898c-d0af2cb448b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameImmuno Control Set
Version Model Number11211A
Catalog Number11211A
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

Device Dimensions

Total Volume4 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store between 2 and 8 degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108058056680204 [Primary]

FDA Product Code

JJYMulti-Analyte Controls, All Kinds (Assayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-25
Device Publish Date2018-11-15

Devices Manufactured by SENTINEL CH. SPA

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08058056680181 - Ammonia Ultra 2023-11-30 The Ammonia Ultra assay is intended for the in vitro quantitative enzymatic determination of ammonia in human plasma using an au
08058056680617 - Lipase Color Liquid2023-07-06 The Lipase Color Liquid is an In Vitro Diagnostic test used for the determination of the lipase activity in serum and plasma by
08058056681911 - CRP Ultra (MP)2022-06-10 Latex immunoassay for the determination of the C-Reactive Protein (CRP) concentration in serum and plasma on VITROS® 4600 Chemi
08058056680136 - Clin Chem Cal2020-12-21 Clin Chem Cal must be used only for the calibration of clinical chemistry tests. For in vitro diagnostic use only.
08058056680099 - Clin Chem Control 12020-03-26 Clin Chem Control 1 is for use in quality control by monitoring accuracy and precision for the quantitative method as specified

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