TOTAL PROTEIN (UP)

GUDID 05055273209587

RANDOX LABORATORIES LIMITED

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• Primary Device ID: 05055273209587
• NIH Device Record Key: a6f4845c-d92f-4c1a-9a9b-e2a2c73c06c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOTAL PROTEIN (UP)
• Version Model Number: UP8113
• Company DUNS: 227530649
• Company Name: RANDOX LABORATORIES LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	05055273209587 [Primary]

FDA Product Code

• JIR: Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

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 [TOTAL PROTEIN (UP)]

• 05055273209587: UP8113
• 05055273206814: For the quantitative in vitro determination of total protein in urine and C.S.F.