Boule Con-Diff Tri-Level 501-605

GUDID 00812137010216

For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff Tri-Level is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific Boule reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product.

CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Full blood count IVD, control
Primary Device ID00812137010216
NIH Device Record Keyfa1cac92-1905-489f-b411-2f4b56fbf940
Commercial Distribution StatusIn Commercial Distribution
Brand NameBoule Con-Diff Tri-Level
Version Model Number6 x 4.5mL
Catalog Number501-605
Company DUNS048144997
Company NameCLINICAL DIAGNOSTIC SOLUTIONS, INC.
Device Count6
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Producttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100812137010216 [Primary]
GS100812137011794 [Unit of Use]

FDA Product Code

JPKMixture, Hematology Quality Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-02

On-Brand Devices [Boule Con-Diff Tri-Level]

00812137011299For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematolo
00812137010230For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematolo
00812137010216For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematolo

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