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 ID: 00831829000168
• NIH Device Record Key: 2af41b04-5b5f-48cd-b0b5-ff2eee7bab79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemataChek Low Control
• Version Model Number: 300-105
• Catalog Number: 300-105
• Company DUNS: 195501127
• Company Name: SEPARATION TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00831829000168 [Primary]

FDA Product Code

• GLK: Control, Hematocrit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-04-18
• Device Publish Date: 2017-08-25

Devices Manufactured by SEPARATION TECHNOLOGY, INC.

• 00831829000458 - 3D Printed Disp. Tube Holders (for HemataSTAT, Cream 50/pkg): 2023-11-14
• 00831829000427 - UltraCrit Loaner: 2023-03-09 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 Tubes: 2018-08-09
• 00831829000281 - ClearCRIT® Plastic Capillary Tubes: 2018-08-09
• 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