Ammonia Reagent

GUDID 00817238011438

Ammonia Reagent

CLINIQA CORPORATION

Ammonia IVD, reagent Ammonia IVD, reagent Ammonia IVD, reagent

• Primary Device ID: 00817238011438
• NIH Device Record Key: 70d0e6c4-0ae7-4544-ab92-33a32237097a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ammonia Reagent
• Version Model Number: R85444
• Company DUNS: 078742335
• Company Name: CLINIQA CORPORATION
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817238011438 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K864706

FDA Product Code

• JIF: Enzymatic Method, Ammonia

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-04
• Device Publish Date: 2018-08-23

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