AIMTAB KETONE TABLETS

GUDID 00695684131005

Tablet test for the detection of ketones (acetoacetic acid and acetone) in urine, serum, plasma, and whole blood. Similar to Acetest, trademark used by Bayer Healthcare, LLC.

GERMAINE LABORATORIES, INC

Ketone (acetoacetate) IVD, reagent

• Primary Device ID: 00695684131005
• NIH Device Record Key: aa4eb819-4337-4400-98ed-2908efd3cd35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIMTAB KETONE TABLETS
• Version Model Number: 13100
• Company DUNS: 176458115
• Company Name: GERMAINE LABORATORIES, INC
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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	00695684131001 [Unit of Use]
GS1	00695684131005 [Primary]

FDA Product Code

• JIN: Nitroprusside, Ketones (Urinary, Non-Quant.)

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: 2018-03-29
• Device Publish Date: 2016-04-27

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