STaK-Chex 225512

GUDID 00844509001188

A whole blood assayed hematology control that offers complete assay values for the 5-part white cell differential available with Beckman Coulter STKS™, MAXM™, HmX and LH 500. Contains 4 vials each of low, normal & high levels.

STRECK, INC.

Full blood count IVD, control

• Primary Device ID: 00844509001188
• NIH Device Record Key: 954a5459-a257-464a-afb2-3e8eaa9ee13b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STaK-Chex
• Version Model Number: 225512
• Catalog Number: 225512
• 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

Device Dimensions

• Total Volume: 4 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844509001188 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K911582

FDA Product Code

• JCN: Control, Cell Counter, Normal And Abnormal

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: 2016-09-19

On-Brand Devices [STaK-Chex]

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• 30844509001158: A whole blood assayed hematology control that offers complete assay values for the 5-part white
• 20844509001168: A whole blood assayed hematology control that offers complete assay values for the 5-part white
• 20844509001151: A whole blood assayed hematology control that offers complete assay values for the 5-part white
• 20844509001144: A whole blood assayed hematology control that offers complete assay values for the 5-part white