Cell-Chex Auto 200068

GUDID 20844509000567

Spinal and body fluid control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid

STRECK, INC.

Full blood count IVD, control

• Primary Device ID: 20844509000567
• NIH Device Record Key: 5d65e590-332b-46ee-aa93-f1aeaa14e209
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cell-Chex Auto
• Version Model Number: 200068
• Catalog Number: 200068
• 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	20844509000567 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053362

FDA Product Code

• JPK: Mixture, Hematology Quality Control

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 [Cell-Chex Auto]

• 00844509000600: Spinal and body fluid control for evaluating the accuracy and precision of hematology instrument
• 00844509000594: Spinal and body fluid control for evaluating the accuracy and precision of hematology instrument
• 00844509000587: Spinal and body fluid control for evaluating the accuracy and precision of hematology instrument
• 20844509000574: Spinal and body fluid control for evaluating the accuracy and precision of hematology instrument
• 20844509000567: Spinal and body fluid control for evaluating the accuracy and precision of hematology instrument
• 20844509000550: Spinal and body fluid control for evaluating the accuracy and precision of hematology instrument