AIMSTRIP US-K

GUDID 00695684501211

Dipstick reagent strips for the qualitative detection of Ketone in Urine.

GERMAINE LABORATORIES, INC

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• Primary Device ID: 00695684501211
• NIH Device Record Key: 4ca260d5-d3dd-465b-aced-7b0095b8782e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIMSTRIP US-K
• Version Model Number: 50121
• Company DUNS: 176458115
• Company Name: GERMAINE LABORATORIES, INC
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00695684501211 [Primary]
GS1	00695684501212 [Unit of Use]

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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