KETONE SERUM CONTROLS

GUDID 00695684131128

Ketone controls for use with ketone tests, 1 Positive and 1 Negative

GERMAINE LABORATORIES, INC

Multiple clinical chemistry enzyme IVD, control Multiple clinical chemistry enzyme IVD, control Multiple clinical chemistry enzyme IVD, control Multiple clinical chemistry enzyme IVD, control Multiple clinical chemistry enzyme IVD, control Multiple clinical chemistry enzyme IVD, control Multiple clinical chemistry enzyme IVD, control Multiple clinical chemistry enzyme IVD, control Multiple clinical chemistry enzyme IVD, control

• Primary Device ID: 00695684131128
• NIH Device Record Key: d7176cf8-0d3d-477f-a825-89579bdfa43d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KETONE SERUM CONTROLS
• Version Model Number: 13112
• Company DUNS: 176458115
• Company Name: GERMAINE LABORATORIES, INC
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00695684131128 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2019-03-11
• Device Publish Date: 2019-02-06

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