Para 12 Plus 218903

GUDID 00844509000211

A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differential instruments. Contains 1 vial each of low, normal and high levels.

STRECK, INC.

Full blood count IVD, control

• Primary Device ID: 00844509000211
• NIH Device Record Key: e7c6d3fd-ac06-4cc7-9949-4f8e7a02776d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Para 12 Plus
• Version Model Number: 218903
• Catalog Number: 218903
• 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	00844509000211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901875

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: 2016-09-14

On-Brand Devices [Para 12 Plus]

• 00844509000235: A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differ
• 00844509000228: A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differ
• 00844509000211: A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differ
• 20844509000208: A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differ
• 20844509000192: A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differ
• 20844509000185: A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differ