AMMONIA (NH3) AM1054

GUDID 05055273200263

RANDOX LABORATORIES LIMITED

Ammonia IVD, kit, enzyme spectrophotometry

• Primary Device ID: 05055273200263
• NIH Device Record Key: 43112fce-3ad3-4e41-9bfa-34f15fef15f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMMONIA (NH3)
• Version Model Number: AM1054
• Catalog Number: AM1054
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273200263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030873

FDA Product Code

• JIF: Enzymatic Method, Ammonia

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: 2019-06-12
• Device Publish Date: 2019-06-04

On-Brand Devices [AMMONIA (NH3)]

• 05055273200263: AM1054
• 05055273200256: AM1015