KOVA 84653

GUDID 00850015517037

KOVA Refractrol SP, Normal Level

KOVA INTERNATIONAL, INC.

Biological stain IVD

• Primary Device ID: 00850015517037
• NIH Device Record Key: e14c2846-f8cf-4d61-8d09-d7d10994e5ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KOVA
• Version Model Number: 84653
• Catalog Number: 84653
• Company DUNS: 078780990
• Company Name: KOVA INTERNATIONAL, 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

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850015517037 [Primary]

FDA Product Code

• ICF: Crystal Violet For Histology

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: 2020-03-17
• Device Publish Date: 2020-03-09

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)