Para 12 Extend 218750

GUDID 00844509000648

A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 6 vials each of low, normal & high levels.

STRECK, INC.

Full blood count IVD, control
Primary Device ID00844509000648
NIH Device Record Keyad590e32-c098-438f-b906-2ec50c370850
Commercial Distribution StatusIn Commercial Distribution
Brand NamePara 12 Extend
Version Model Number218750
Catalog Number218750
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 Volume2.5 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100844509000648 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GLQMixture, Control, White-Cell And Red-Cell Indices

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 Extend]

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00844509000648A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Co
50844509000612A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Co
40844509000639A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Co
40844509000622A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Co
40844509000615A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Co
30844509000632A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Co
30844509000625A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Co
30844509000618A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Co

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