CVA 291711

GUDID 00844509001416

Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of RBC L1-5, WBC L1-4, PLT L1-5.

STRECK, INC.

Full blood count IVD, control

• Primary Device ID: 00844509001416
• NIH Device Record Key: 65df68d4-5f82-4590-ae92-98808f906b89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CVA
• Version Model Number: 291711
• Catalog Number: 291711
• 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	00844509001416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960557

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 [CVA]

• 00844509001669: Assayed linearity control kits that are used to determine the patient reportable range of 3-part
• 00844509001447: Assayed linearity control kits that are used to determine the patient reportable range of 3-part
• 00844509001430: Assayed linearity control kits that are used to determine the patient reportable range of 3-part
• 00844509001423: Assayed linearity control kits that are used to determine the patient reportable range of 3-part
• 00844509001416: Assayed linearity control kits that are used to determine the patient reportable range of 3-part
• 00844509001409: Assayed linearity control kits that are used to determine the patient reportable range of 3-part
• 00844509001393: Assayed linearity control kits that are used to determine the patient reportable range of 3-part
• 00844509001386: Assayed linearity control kits that are used to determine the patient reportable range of 3-part
• 00844509001379: Assayed linearity control kits that are used to determine the patient reportable range of 3-part