KETO-DIASTIX® 2883

GUDID 40301932883500

Reagent Strips for Urinalysis: Ketone; Glucose

ASCENSIA DIABETES CARE US INC.

Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Primary Device ID40301932883500
NIH Device Record Key4ca9ef20-05e0-4e9f-af3f-7c22ec312b1f
Commercial Distribution StatusIn Commercial Distribution
Brand NameKETO-DIASTIX®
Version Model Number2883
Catalog Number2883
Company DUNS080028910
Company NameASCENSIA DIABETES CARE US INC.
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com
Phone800-348-8100
Emailsupport@contournext.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store 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 TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store 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 TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store 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 TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store 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 TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store 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 TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store 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 TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store 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 TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store 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 TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store 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 TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store 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 TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store 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 TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store 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 TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store 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 TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store 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 TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store 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 TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store 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 TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store 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 TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store 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 TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store 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 TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store 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 TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store 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 TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store 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 TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store 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 TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store 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 TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store 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 TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100301932883014 [Unit of Use]
GS100301932883502 [Package]
Contains: 10301932883509
Package: carton [1 Units]
In Commercial Distribution
NDC/NHRIC0193-2882-50 [Secondary]
GS110301932883509 [Primary]
GS140301932883500 [Package]
Contains: 00301932883502
Package: shipper/case [24 Units]
In Commercial Distribution

FDA Product Code

JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
JINNitroprusside, Ketones (Urinary, Non-Quant.)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-01-21
Device Publish Date2019-06-06

On-Brand Devices [KETO-DIASTIX®]

40301932883500Reagent Strips for Urinalysis: Ketone; Glucose
40301932882213Reagent Strips for Urinalysis: Ketone; Glucose

Trademark Results [KETO-DIASTIX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
KETO-DIASTIX
KETO-DIASTIX
72376649 0930307 Live/Registered
MILES LABORATORIES, INC.
1970-11-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.