Clin Chem Cal 16550

GUDID 08058056680136

Clin Chem Cal must be used only for the calibration of clinical chemistry tests. For in vitro diagnostic use only.

SENTINEL CH. SPA

Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator
Primary Device ID08058056680136
NIH Device Record Key7c8d669a-3d83-4b1c-8899-039fef150ec1
Commercial Distribution StatusIn Commercial Distribution
Brand NameClin Chem Cal
Version Model Number16550
Catalog Number16550
Company DUNS429572365
Company NameSENTINEL CH. SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it
Phone9999999999
Emailcustomerservice@sentinel.it

Device Dimensions

Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS108058056680136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JIXCalibrator, Multi-Analyte Mixture

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-12-21
Device Publish Date2016-06-29

Devices Manufactured by SENTINEL CH. SPA

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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 Cal2020-12-21Clin Chem Cal must be used only for the calibration of clinical chemistry tests. For in vitro diagnostic use only.
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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