Cell-Chex Auto 200065

GUDID 00844509000587

Spinal and body fluid control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid samples. Contains 1 vial each of level 2 & 3.

STRECK, INC.

Full blood count IVD, control

• Primary Device ID: 00844509000587
• NIH Device Record Key: 42bba79f-a0fe-4fc0-8a14-034f08b0856e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cell-Chex Auto
• Version Model Number: 200065
• Catalog Number: 200065
• 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: 3 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844509000587 [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