Cell-Chex 212425

GUDID 00844509000297

Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC) counts, crystal identification, and white blood cell differentiation. Contains 6 vials each of L1-UC and L2.

STRECK, INC.

Full blood count IVD, control

• Primary Device ID: 00844509000297
• NIH Device Record Key: 3b7f91d6-59d5-4518-abdd-fc29b9896597
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cell-Chex
• Version Model Number: 212425
• Catalog Number: 212425
• 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: 2 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844509000297 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101335

FDA Product Code

• GLQ: Mixture, Control, White-Cell And Red-Cell Indices

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]

• 00844509000303: Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC)
• 00844509000297: Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC)
• 00844509000280: Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC)
• 30844509000267: Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC)
• 20844509000277: Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC)
• 20844509000260: Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC)
• 20844509000253: Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC)