CALCIUM (Ca)

GUDID 05055273208368

RANDOX LABORATORIES LIMITED

Calcium (Ca2+) IVD, kit, spectrophotometry

• Primary Device ID: 05055273208368
• NIH Device Record Key: b0585049-4294-4122-bdba-7e1f96401beb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CALCIUM (Ca)
• Version Model Number: CA8309
• Company DUNS: 227530649
• Company Name: RANDOX LABORATORIES LIMITED
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273208368 [Primary]

FDA Product Code

• CJY: Azo Dye, Calcium

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-11
• Device Publish Date: 2019-06-03

On-Brand Devices [CALCIUM (Ca)]

• 05055273200881: The calcium test system is a device intended for the quantitative in vitro determination of calc
• 05055273208368: CA8309