GammaZyme-B 0007058

GUDID 10888234000716

GammaZyme-B is used in one-stage enzyme test systems for blood group antibody detection. GammaZyme-B is a stabilized solution of bromelin, and this pr

IMMUCOR, INC.

Bromelin immunohaematology reagent IVD

• Primary Device ID: 10888234000716
• NIH Device Record Key: 9d5f0920-74a5-4b75-9b85-8752715c8602
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GammaZyme-B
• Version Model Number: 0007058
• Catalog Number: 0007058
• Company DUNS: 061446282
• Company Name: IMMUCOR, 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: false
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-855-466-8267
• Email: tech_support@immucor.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234000716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK880016

FDA Product Code

• KSK: Solution, Stabilized Enzyme

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: 2016-04-15

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