FDA.reportPublic FDA data

KETOSTIX®

Primary DI
40301932881216
Brand
KETOSTIX®
Company
ASCENSIA DIABETES CARE US INC.
Model
2881
Catalog number
2881
Device description
Reagent Strips for Urinalysis: Ketone
Published
2019-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JINNitroprusside, Ketones (Urinary, Non-Quant.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JINNitroprusside, Ketones (Urinary, Non-Quant.)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00301932881218PackageGS11In Commercial Distribution
40301932881216PackageGS112In Commercial Distribution
10301932881215PrimaryGS10
0193-2880-21SecondaryNDC/NHRIC0
00301932881010Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00301932881218003019328812183019328812180301932881218
4030193288121640301932881216
1030193288121510301932881215
00301932881010003019328810103019328810100301932881010

GMDN Terms#

Term, Definition table
TermDefinition
Urine ketone IVD, kit, colorimetric dipstick, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative screening of urine for ketones within a short period relative to standard laboratory testing procedures, using a colorimetric dipstick method. This test is commonly used in the laboratory or in point-of-care analyses.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Read enclosed directions carefully. Use within 6 mos after first open. Tamper evident seal.
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-348-8100support@contournext.com

Regulatory Flags#

DUNS number
080028910
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10301937080507CONTOUR®7080G67071132016-09-16
00301936260019CONTOUR® NEXT LINK 2.46260819146722016-08-25
00301936020217MICROLET® NEXT6020900122812026-03-16
00301936021214MICROLET® NEXT6021900122822026-03-16
40301936020215MICROLET® NEXT6020900122812026-03-16
40301936021212MICROLET® NEXT6021900122822026-03-16
10301937277358CONTOUR® NEXT7277857231542017-11-03
10301937278706CONTOUR® NEXT7278857012312017-11-03
00301936262013CONTOUR® NEXT LINK 2.46262850929792016-08-25
00301939658011CONTOUR® NEXT GEN9658900029042022-06-30
00301937035029CONTOUR® PLUS BLUE7035900062072025-01-06
10301937309509CONTOUR® NEXT7309836230802016-08-25
10301937310253CONTOUR® NEXT7310836230992016-08-25
10301937311502CONTOUR® NEXT7311836247102016-08-25
10301937312219CONTOUR® NEXT7312836247882016-08-25
10301937314015CONTOUR® NEXT7314836248182016-09-16
10301937315012CONTOUR® NEXT7315836248262016-09-16
10301937550154CONTOUR®NEXT7550900011742019-08-30
00301937036019CONTOUR® PLUS BLUE7036900083812024-08-01
00301937383014CONTOUR® NEXT GEN7383900048502022-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.JIN2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.JIN2026-04-16
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2026-04-16
00816042016417FORAFORA CARE INC.JIN2026-03-20
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
00860015091642KetoBMKETOBM USA LLCJIN2026-01-19
00199284689879SureMediks B-Ketone Test Strips (25pcs/box)Rasimo Systems LLCJIN2025-12-05
04710469879548XPER Technology Multi-Functional Monitoring System Procheck SmartTAIDOC TECHNOLOGY CORPORATIONJIN2025-10-30
04710469879555XPER Technology Multi-Functional Monitoring System Procheck WittyTAIDOC TECHNOLOGY CORPORATIONJIN2025-10-30
04719893233841XPER Technology Procheck Witty Procheck Smart B-Ketone Test StripsTAIDOC TECHNOLOGY CORPORATIONJIN2025-10-30
00850014861681heartscare B-Ketone Test Strips (10pcs/Box)Hearts Bio, Inc.JIN2025-10-01
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIN2025-09-18
00850014861575HeartsCare C1 Plus Multi-Functional Monitoring SystemHearts Bio, Inc.JIN2025-07-02
00850014861056HeartsCare C1 Plus Multi-Functional Monitoring SystemHearts Bio, Inc.JIN2025-03-31
00816042015199FORAFORA CARE INC.JIN2025-03-14
80816042015195FORAFORA CARE INC.JIN2025-03-14
00850054026729QMedix™Diagnostic Automation, Inc.JIN2024-10-29
00816042015069FORAFORA CARE INC.JIN2024-10-01
00816042015076FORAFORA CARE INC.JIN2024-10-01
80816042015065FORAFORA CARE INC.JIN2024-10-01
80816042015072FORAFORA CARE INC.JIN2024-10-01
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2024-06-14
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJIN2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJIN2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJIN2024-06-04
00816042015182FORAFORA CARE INC.JIN2024-04-19
80816042015188FORAFORA CARE INC.JIN2024-04-19