Mission Urinalysis Reagent Strips

GUDID 00682607000364

Mission Urinalysis Reagent Strips (KET)

ACON LABORATORIES, INC.

Urine ketone IVD, kit, colorimetric dipstick, rapid

• Primary Device ID: 00682607000364
• NIH Device Record Key: a14a98e4-f732-46d1-a1df-9f3821604586
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mission Urinalysis Reagent Strips
• Version Model Number: U031-011
• Company DUNS: 781100966
• Company Name: ACON 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00682607000364 [Primary]
GS1	00682607000722 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061559

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: 4
• Public Version Date: 2019-07-22
• Device Publish Date: 2016-09-24

On-Brand Devices [Mission Urinalysis Reagent Strips]

• 20682607200416: Mission Urinalysis Reagent Strips (ASC/GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT/LEU)
• 20682607200409: Mission Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT/LEU)
• 20682607200393: Mission Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT)
• 20682607200386: Mission Urinalysis Reagent Strips (PH/GLU/BIL/PRO/URO/NIT/LEU/KET)
• 20682607200379: Mission Urinalysis Reagent Strips (GLU/SG/BLO/PH/PRO/URO/NIT/LEU)
• 20682607200362: Mission Urinalysis Reagent Strips (GLU/KET/SG/BLO/PH/PRO/NIT/LEU)
• 20682607200355: Mission Urinalysis Reagent Strips (GLU/BIL/KET/BLO/PH/PRO/URO/NIT)
• 20682607200348: Mission Urinalysis Reagent Strips (GLU/KET/PRO/PH/BLO/NIT/LEU)
• 20682607200331: Mission Urinalysis Reagent Strips (BIL/SG/BLO/URO/PRO/NIT)
• 20682607200324: Mission Urinalysis Reagent Strips (GLU/PRO/PH/BLO/NIT/LEU)
• 20682607200317: Mission Urinalysis Reagent Strip (BIL/URO/LEU/NIT/BLO)
• 20682607200300: Mission Urinalysis Reagent Strip (GLU/SG/PRO/PH/BLO)
• 20682607200294: Mission Urinalysis Reagent Strips (GLU/PRO/NIT/BLO/LEU)
• 20682607200287: Mission Urinalysis Reagent Strip (GLU/KET/PRO/PH/BLO)
• 20682607200270: Mission Urinalysis Reagent Strips (PRO/NIT/BLO/LEU)
• 20682607200263: Mission Urinalysis Reagent Strip (PRO/GLU/LEU/BLO)
• 20682607200256: Mission Urinalysis Reagent Strip (GLU/KET/PRO/PH)
• 20682607200249: Mission Urinalysis Reagent Strip (GLU/PRO/PH/BLO)
• 20682607200232: Mission Urinalysis Reagent Strip (GLU/SG/PH/PRO)
• 20682607200225: Mission Urinalysis Reagent Strip (GLU/PRO/NIT/LEU)
• 20682607200218: Mission Urinalysis Reagent Strip (BLO/NIT/LEU)
• 20682607200201: Mission Urinalysis Reagent Strips (GLU/KET/PH)
• 20682607200195: Mission Urinalysis Reagent Strips (GLU/KET/PRO)
• 20682607200188: Mission Urinalysis Reagent Strips (GLU/PH/PRO)
• 20682607200171: Mission Urinalysis Reagent Strips (ALB/CRE)
• 20682607200164: Mission Urinalysis Reagent Strips (SG/PH)
• 20682607200157: Mission Urinalysis Reagent Strips (BIL/URO)
• 20682607200140: Mission Urinalysis Reagent Strips (BLO/LEU)
• 20682607200133: Mission Urinalysis Reagent Strips (NIT/LEU)
• 20682607200126: Mission Urinalysis Reagent Strips (GLU/KET)
• 20682607200119: Mission Urinalysis Reagent Strips (GLU/PRO)
• 20682607200102: Mission Urinalysis Reagent Strips (PRO)
• 20682607200096: Mission Urinalysis Reagent Strips (KET)
• 20682607200089: Mission Urinalysis Reagent Strips (GLU)
• 20682607200072: Mission Urinalysis Reagent Strips (PH)
• 20682607200065: Mission Urinalysis Reagent Strips (BLO)
• 00682607000685: Mission Urinalysis Reagent Strips (ASC/GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT/LEU)
• 00682607000678: Mission Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT/LEU)
• 00682607000661: Mission Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT)
• 00682607000654: Mission Urinalysis Reagent Strips (PH/GLU/BIL/PRO/URO/NIT/LEU/KET)
• 00682607000647: Mission Urinalysis Reagent Strips (GLU/SG/BLO/PH/PRO/URO/NIT/LEU)
• 00682607000630: Mission Urinalysis Reagent Strips (GLU/KET/SG/BLO/PH/PRO/NIT/LEU)
• 00682607000623: Mission Urinalysis Reagent Strips (GLU/BIL/KET/BLO/PH/PRO/URO/NIT)
• 00682607000616: Mission Urinalysis Reagent Strips (GLU/KET/PRO/PH/BLO/NIT/LEU)
• 00682607000609: Mission Urinalysis Reagent Strips (BIL/SG/BLO/URO/PRO/NIT)
• 00682607000593: Mission Urinalysis Reagent Strips (GLU/PRO/PH/BLO/NIT/LEU)
• 00682607000586: Mission Urinalysis Reagent Strip (BIL/URO/LEU/NIT/BLO)
• 00682607000579: Mission Urinalysis Reagent Strip (GLU/SG/PRO/PH/BLO)
• 00682607000562: Mission Urinalysis Reagent Strips (GLU/PRO/NIT/BLO/LEU)
• 00682607000555: Mission Urinalysis Reagent Strip (GLU/KET/PRO/PH/BLO)