KOVA 87332E

GUDID 00855617006231

KOVA-Trol I: High Abnormal w/ urobilinogen (4x60 mL)

KOVA INTERNATIONAL, INC.

Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control Urine sediment IVD, control

• Primary Device ID: 00855617006231
• NIH Device Record Key: 4c070db2-9c13-44b3-b07c-7b3b9bb72570
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KOVA
• Version Model Number: 87332E
• Catalog Number: 87332E
• Company DUNS: 078780990
• Company Name: KOVA INTERNATIONAL, INC.
• 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: 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

Customer Support Contacts

• Phone: 714-902-1700
• Email: cs@kovaintl.com
• Phone: 714-902-1700
• Email: cs@kovaintl.com
• Phone: 714-902-1700
• Email: cs@kovaintl.com
• Phone: 714-902-1700
• Email: cs@kovaintl.com
• Phone: 714-902-1700
• Email: cs@kovaintl.com
• Phone: 714-902-1700
• Email: cs@kovaintl.com
• Phone: 714-902-1700
• Email: cs@kovaintl.com
• Phone: 714-902-1700
• Email: cs@kovaintl.com
• Phone: 714-902-1700
• Email: cs@kovaintl.com
• Phone: 714-902-1700
• Email: cs@kovaintl.com
• Phone: 714-902-1700
• Email: cs@kovaintl.com
• Phone: 714-902-1700
• Email: cs@kovaintl.com
• Phone: 714-902-1700
• Email: cs@kovaintl.com
• Phone: 714-902-1700
• Email: cs@kovaintl.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855617006231 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K843565

FDA Product Code

• JJW: Urinalysis 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: 2020-08-07
• Device Publish Date: 2020-07-30

On-Brand Devices [KOVA]

• 00850015517068: KOVA Refractrol, Low 6.0
• 00850015517051: KOVA Refractrol, High 9.0
• 00850015517044: KOVA Refractrol SP, High Level
• 00850015517037: KOVA Refractrol SP, Normal Level
• 00850015517020: KOVA Refractrol SP, Low Level
• 00850015517013: Super-Pac 1000 International
• 00850015517006: Super-Pac 1000
• 00855617006613: KOVA-TROL I 4X60ML HIGH ABNORMAL
• 00855617006293: KOVA-Trol III Normal w/hCG (4x60 mL)
• 00855617006255: KOVA-Trol I: High Abnormal w/ urobilinogen (4x15 mL)
• 00855617006231: KOVA-Trol I: High Abnormal w/ urobilinogen (4x60 mL)
• 00855617006217: KOVA-Trol I: High Abnormal (4x60 mL)
• 00855617006200: KOVA-Trol I: High Abnormal (4x15 mL)
• 00855617006194: Caps, 500 Caps
• 00855617006187: Petters, 500 Petters
• 00855617006170: Economy Tubes, 500 Tubes
• 00855617006163: Super Tubes, 500 Tubes
• 00855617006156: Glasstic Slide 10, 500 Determinations
• 00855617006149: Glasstic Slide 10, 1000 Determinations
• 00855617006132: Glasstic Slide 10 with Grids, 1000 determinations
• 00855617006125: Slide II, 400 Determinations
• 00855617006118: Slide II with Grids, 400 Determinations
• 00855617006101: KO-LEC-PAC, 500 Determinations
• 00855617006095: Value Pac 500, 500 Determinations
• 00855617006088: Pac II
• 00855617006071: Super Pac 1000
• 00855617006064: Super Pac 1000 and Caps
• 00855617006057: KOVA Stain
• 00855617006040: Level I (Abnormal) w/ microscopics
• 00855617006033: Level II (Normal) w/hCG and microscopics
• 00855617006026: KOVA Liqua-Trol Level I (Abnormal) w/ microscopics
• 00855617006019: Level II (Normal) w/hCG and Microscopics
• 00855617006002: Level I Abnormal and Level II Normal with hCG
• 00850015517150: KOVA TROL III (4 x 15mL)
• 00850015517143: KOVA TROL I (4 x 15mL)
• 00850015517136: KOVA TROL II (4 x 15mL)
• 00850015517129: K. SLIDE 10, 10x100
• 00850015517105: ONO PETTER, 1000/box
• 00850015517082: FastRead Slides w/grids
• 00850015517075: KOVA-poc, Urinalysis System Pac
• 00855617006514: 1000 with grids
• 00855617006507: 500 with grids
• 00855617006491: 1000 with grids
• 00855617006484: 50 slides
• 00855617006453: 2x12mL International
• 00855617006446: 2x12mL Domestic
• 00855617006439: 1x120mL vial abnormal and 1x20mL vial normal
• 00855617006422: KOVA-Trol II: Low Abnormal (10x60 mL)
• 00855617006415: KOVA-TROL I High Abnormal with urobillinogen (8x60mL) Quest
• 00855617006408: KOVA-TROL I High Abnormal with urobillinogen (8x60mL)