HemataChek Low Control 300-105

GUDID 00831829000168

HemataChek is a three-level micro-hematocrit reference control for monitoring the accuracy and presision of the HemataStat™Centrifuges and other methods used to measure whole blood spun hematacit values.

SEPARATION TECHNOLOGY, INC.

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Primary Device ID00831829000168
NIH Device Record Key2af41b04-5b5f-48cd-b0b5-ff2eee7bab79
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemataChek Low Control
Version Model Number300-105
Catalog Number300-105
Company DUNS195501127
Company NameSEPARATION TECHNOLOGY, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18005315535
Emailstanbiolab@ekfdiagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100831829000168 [Primary]

FDA Product Code

GLKControl, Hematocrit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-04-18
Device Publish Date2017-08-25

Devices Manufactured by SEPARATION TECHNOLOGY, INC.

00831829000458 - 3D Printed Disp. Tube Holders (for HemataSTAT, Cream 50/pkg)2023-11-14
00831829000427 - UltraCrit Loaner2023-03-09 UltraCrit Hematocrit measurement device (UltraCrit) employs ultrasound technology to accurately measure hematocrit (Hct) in whol
00831829000410 - HemataSTAT II Centrifuge 2022-04-08 HemataStat II Microhematocrit System is a small, lightweight centrifuge which provides a rapid and accurate mircohematocrit det
00831829000267 - ClearCRIT® Plastic Capillary Tubes2018-08-09
00831829000281 - ClearCRIT® Plastic Capillary Tubes2018-08-09
00831829000304 - ClearCrit Mylar®Coated Glass Capillary Tubes 2018-08-09
00831829000328 - ClearCRIT Self-Sealing ®Mylar®Wrapped Capillary Tubes 2018-08-09
00831829000403 - ClearCRIT Self-Sealing ®Mylar®Wrapped Capillary Tubes 2018-08-09

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