CVA 291714

GUDID 00844509001447

Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of PLT L1-6.

STRECK, INC.

Full blood count IVD, control
Primary Device ID00844509001447
NIH Device Record Keyfdb5db82-8b04-4a7b-b32a-12fad66a91cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameCVA
Version Model Number291714
Catalog Number291714
Company DUNS072915986
Company NameSTRECK, INC.
Device Count1
DM Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-228-6090
Emailcustserv@streck.com

Device Dimensions

Total Volume3 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100844509001447 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

On-Brand Devices [CVA]

00844509001669Assayed linearity control kits that are used to determine the patient reportable range of 3-part
00844509001447Assayed linearity control kits that are used to determine the patient reportable range of 3-part
00844509001430Assayed linearity control kits that are used to determine the patient reportable range of 3-part
00844509001423Assayed linearity control kits that are used to determine the patient reportable range of 3-part
00844509001416Assayed linearity control kits that are used to determine the patient reportable range of 3-part
00844509001409Assayed linearity control kits that are used to determine the patient reportable range of 3-part
00844509001393Assayed linearity control kits that are used to determine the patient reportable range of 3-part
00844509001386Assayed linearity control kits that are used to determine the patient reportable range of 3-part
00844509001379Assayed linearity control kits that are used to determine the patient reportable range of 3-part

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