FDA.reportPublic FDA data

KOVA

Primary DI
00855617006040
Brand
KOVA
Company
KOVA INTERNATIONAL, INC.
Model
87177E
Catalog number
87177E
Device description
Level I (Abnormal) w/ microscopics
Published
2020-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJWUrinalysis Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJWUrinalysis Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855617006040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855617006040008556170060408556170060400855617006040

GMDN Terms#

Term, Definition table
TermDefinition
Urine sediment IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or semi-quantitative screening of urine sediment.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
714-902-1700cs@kovaintl.com

Regulatory Flags#

DUNS number
078780990
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850015517198Siemens11561696115616962022-03-03
00850015517204Siemens11561695115616952022-03-03
00850015517211Siemens11561694115616942022-03-03
00855617006873KOVA87162871622020-08-12
00855617006521Cardinal Health89102891022020-08-13
00855617006538Cardinal Health89101891012020-08-13
00855617006903KOVA87155871552020-08-12
00855617006910KOVA87153871532020-08-12
00855617006958KOVA87138871382020-08-12
00855617006965KOVA87137871372020-08-12
00855617006804KOVA87140871402020-08-11
00855617006934KOVA87141871412020-08-11
00850015517075KOVA88100881002020-07-30
00855617006064KOVA87153E87153E2020-07-30
00855617006071KOVA87162E87162E2020-07-30
00855617006088KOVA87155E87155E2020-07-30
00855617006095KOVA87156E87156E2020-07-30
00855617006101KOVA87141E87141E2020-07-30
00855617006163KOVA87137E87137E2020-07-30
00855617006170KOVA87138E87138E2020-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751582Urinalysis ControlUrit Medical Electronic Co., Ltd.JJW2026-06-26
06935740751605Maintenance AgentUrit Medical Electronic Co., Ltd.JJW2026-06-26
06935740751612SG ControlUrit Medical Electronic Co., Ltd.JJW2026-06-26
06935740751629Color ControlUrit Medical Electronic Co., Ltd.JJW2026-06-26
06935740751636Turbidity ControlUrit Medical Electronic Co., Ltd.JJW2026-06-26
06935740751643SG CalibratorUrit Medical Electronic Co., Ltd.JJW2026-06-26
06935740751650Turbidity CalibratorUrit Medical Electronic Co., Ltd.JJW2026-06-26
06935740751667Mutiple Control for SGUrit Medical Electronic Co., Ltd.JJW2026-06-26
50885380126091CARDINAL HEALTHCardinal Health 200, LLCJJW2026-06-10
50885380126107CARDINAL HEALTHCardinal Health 200, LLCJJW2026-06-10
06935740750653Calibrator Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750660Calibrator Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750677Calibrator Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750684Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750691Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750707Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750714Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.JJW2026-04-16
06935740750721Urinalysis ControlUrit Medical Electronic Co., Ltd.JJW2026-04-16
00682607200672Mission Liquid Urine ControlsAcon Laboratories, Inc.JJW2025-04-17
00682607200689Mission Liquid Urine ControlsAcon Laboratories, Inc.JJW2025-04-17
00682607200696Mission Liquid Urine ControlsAcon Laboratories, Inc.JJW2025-04-17
00682607200702Mission Liquid Urine ControlsAcon Laboratories, Inc.JJW2025-04-17
20682607200676Mission Liquid Urine ControlsACON LABORATORIES, INC.JJW2025-04-17
20682607200683Mission Liquid Urine ControlsACON LABORATORIES, INC.JJW2025-04-17
20682607200690Mission Liquid Urine ControlsACON LABORATORIES, INC.JJW2025-04-17
20682607200706Mission Liquid Urine ControlsACON LABORATORIES, INC.JJW2025-04-17
07290012140136QwikCheck BeadsM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.JJW2023-06-08
07290012140600QwikCheck Beads Proficiency and Training KitM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.JJW2023-06-08
07290016650020QwikCheck Beads Precision and Linearity kitM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.JJW2023-06-08
00896863002424Chromascopics Control Level 1&2 Set 2x25mL (International)QUANTIMETRIX CORPORATIONJJW2023-05-04