Cell-Chex 212424

GUDID 20844509000277

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

STRECK, INC.

Full blood count IVD, control Full blood count IVD, control

• Primary Device ID: 20844509000277
• NIH Device Record Key: 883c80b8-be22-4c15-b0a0-38f10c319326
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cell-Chex
• Version Model Number: 212424
• Catalog Number: 212424
• 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: 2 Milliliter
• Total Volume: 2 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	20844509000277 [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)