Para 4 215428

GUDID 00844509000815

A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contains 4 vials each of normal & high levels.

STRECK, INC.

Full blood count IVD, control
Primary Device ID00844509000815
NIH Device Record Keyff367af2-2c1b-4cd5-83b3-ddb84b4f43c8
Commercial Distribution StatusIn Commercial Distribution
Brand NamePara 4
Version Model Number215428
Catalog Number215428
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 Volume1.5 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100844509000815 [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 Date2016-09-14

On-Brand Devices [Para 4]

00844509000815A multi-parameter hematology control for small laboratories and point-of-care applications that
00844509000808A multi-parameter hematology control for small laboratories and point-of-care applications that
00844509000792A multi-parameter hematology control for small laboratories and point-of-care applications that
00844509000785A multi-parameter hematology control for small laboratories and point-of-care applications that
00844509000778A multi-parameter hematology control for small laboratories and point-of-care applications that
00844509000761A multi-parameter hematology control for small laboratories and point-of-care applications that
00844509000754A multi-parameter hematology control for small laboratories and point-of-care applications that
00844509000747A multi-parameter hematology control for small laboratories and point-of-care applications that
00844509000730A multi-parameter hematology control for small laboratories and point-of-care applications that
00844509000723A multi-parameter hematology control for small laboratories and point-of-care applications that
00844509000716A multi-parameter hematology control for small laboratories and point-of-care applications that
40844509000707A multi-parameter hematology control for small laboratories and point-of-care applications that
40844509000691A multi-parameter hematology control for small laboratories and point-of-care applications that
40844509000684A multi-parameter hematology control for small laboratories and point-of-care applications that
30844509000700A multi-parameter hematology control for small laboratories and point-of-care applications that
30844509000694A multi-parameter hematology control for small laboratories and point-of-care applications that
30844509000687A multi-parameter hematology control for small laboratories and point-of-care applications that

Trademark Results [Para 4]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PARA 4
PARA 4
97747931 not registered Live/Pending
Microbe Formulas, LLC
2023-01-10
PARA 4
PARA 4
87080205 5119475 Live/Registered
Streck, Inc.
2016-06-22
PARA 4
PARA 4
73494570 1363924 Dead/Cancelled
STRECK LABORATORIES, INC.
1984-08-13

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