POINTE SCIENTIFIC CK-MB Controls C7562-12

GUDID 00811727010971

This CK-MB Isoenzyme Control has been assayed for CK-MB and is intended to be used as a human serum control product for CK-MB determinations.

POINTE SCIENTIFIC, INC.

Creatine kinase myocardial isoenzyme (CKMB) IVD, control

• Primary Device ID: 00811727010971
• NIH Device Record Key: 3e92c450-0a4e-440d-ac17-a1d15b330b5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POINTE SCIENTIFIC CK-MB Controls
• Version Model Number: C7562-12
• Catalog Number: C7562-12
• Company DUNS: 045623154
• Company Name: POINTE SCIENTIFIC, INC.
• Device Count: 1
• DM Exempt: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811727010971 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954074

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

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: 2016-08-31

Devices Manufactured by POINTE SCIENTIFIC, INC.

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