Para 12 Plus 218907

GUDID 00844509000228

A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differential instruments. Contains 2 vials each of low, normal and high levels.

STRECK, INC.

Full blood count IVD, control
Primary Device ID00844509000228
NIH Device Record Keyc3682b2c-92ce-45c1-b090-562705898888
Commercial Distribution StatusIn Commercial Distribution
Brand NamePara 12 Plus
Version Model Number218907
Catalog Number218907
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
GS100844509000228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JCNControl, Cell Counter, Normal And Abnormal

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 Date2016-09-14

On-Brand Devices [Para 12 Plus]

00844509000235A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differ
00844509000228A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differ
00844509000211A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differ
20844509000208A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differ
20844509000192A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differ
20844509000185A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differ

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