Cal-Chex 221101

GUDID 20844509000246

A hematology calibrator assayed for Beckman Coulter®, Abbott, Horiba Medical, HTI, and Mindray instruments. Contains 1 vial.

STRECK, INC.

Full blood count IVD, calibrator

• Primary Device ID: 20844509000246
• NIH Device Record Key: 5252aa02-2cb0-425f-a1ec-05b833b25c80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cal-Chex
• Version Model Number: 221101
• Catalog Number: 221101
• Company DUNS: 072915986
• Company Name: STRECK, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-228-6090
• Email: custserv@streck.com
• Phone: 1-800-228-6090
• Email: custserv@streck.com

Device Dimensions

• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	20844509000246 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K840261

FDA Product Code

• KRZ: Calibrator For Hemoglobin And Hematocrit Measurement

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: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [Cal-Chex]

• 30844509000243: A hematology calibrator assayed for Beckman Coulter®, Abbott, Horiba Medical, HTI, and Mindray
• 20844509000246: A hematology calibrator assayed for Beckman Coulter®, Abbott, Horiba Medical, HTI, and Mindray