CD-Chex Plus BC 213375

GUDID 00844509000532

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials each of CD4L and Normal level.

STRECK, INC.

Multiple CD cell marker IVD, control

• Primary Device ID: 00844509000532
• NIH Device Record Key: 2e8b8113-9a6f-4a5e-92ad-47193df4d39b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CD-Chex Plus BC
• Version Model Number: 213375
• Catalog Number: 213375
• 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
• Phone: 1-800-228-6090
• Email: custserv@streck.com
• Phone: 1-800-228-6090
• Email: custserv@streck.com
• Phone: 1-800-228-6090
• Email: custserv@streck.com
• Phone: 1-800-228-6090
• Email: custserv@streck.com
• Phone: 1-800-228-6090
• Email: custserv@streck.com
• Phone: 1-800-228-6090
• Email: custserv@streck.com
• Phone: 1-800-228-6090
• Email: custserv@streck.com
• Phone: 1-800-228-6090
• Email: custserv@streck.com
• Phone: 1-800-228-6090
• Email: custserv@streck.com
• Phone: 1-800-228-6090
• Email: custserv@streck.com
• Phone: 1-800-228-6090
• Email: custserv@streck.com
• Phone: 1-800-228-6090
• Email: custserv@streck.com
• Phone: 1-800-228-6090
• Email: custserv@streck.com
• Phone: 1-800-228-6090
• Email: custserv@streck.com
• Phone: 1-800-228-6090
• Email: custserv@streck.com

Device Dimensions

• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• 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	00844509000532 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051633

FDA Product Code

• GGL: Control, White-Cell

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 [CD-Chex Plus BC]

• 00844509000549: A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vi
• 00844509000532: A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vi
• 40844509000523: A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 via
• 40844509000516: A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vi
• 30844509000526: A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vi
• 30844509000519: A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vi
• 20844509000529: A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vi
• 20844509000512: A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vi