FDA.reportPublic FDA data

DIASTIX®

Primary DI
40301932806509
Brand
DIASTIX®
Company
ASCENSIA DIABETES CARE US INC.
Model
2806
Catalog number
2806
Device description
Reagent strips for urinalysis - glucose. 50 test strips.
Published
2016-09-16
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
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)Clinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K831600000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K831600000DIASTIX REAGENT STRIPS FOR URINALYSISMiles Laboratories, Inc.1983-09-08JIL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00301932806501PackageGS11In Commercial Distribution
40301932806509PackageGS124In Commercial Distribution
10301932806508PrimaryGS10
0193-2802-50SecondaryNDC/NHRIC0
00301932806013Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00301932806501003019328065013019328065010301932806501
4030193280650940301932806509
1030193280650810301932806508
00301932806013003019328060133019328060130301932806013

GMDN Terms#

Term, Definition table
TermDefinition
Urine glucose 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 glucose 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, Specify00Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18003488100support@contournext.com

Regulatory Flags#

DUNS number
080028910
Device count
50
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.JIL2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.JIL2026-04-16
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIL2026-04-16
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIL2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIL2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIL2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIL2026-02-06
00015482104658AUTION MAX™ AX-4060 AnalyzerARKRAY USA, INC.JIL2025-11-07
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIL2025-09-18
00015482117313AUTION MAX™ AX-4060 AnalyzerARKRAY USA, INC.JIL2024-12-02
00850054026729QMedix™Diagnostic Automation, Inc.JIL2024-10-29
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIL2024-06-14
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJIL2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJIL2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJIL2024-06-04
10673486002416Teco Diagnostics Urine Reagent Strips (URS-1G)TECO DIAGNOSTICSJIL2024-03-22
00657498002094Uri-Trak 120 M Urine AnalyzerSTANBIO LABORATORY, L.P.JIL2023-06-08
10888277720336MedlineMEDLINE INDUSTRIES, INC.JIL2022-12-10
10884389181966MedlineMEDLINE INDUSTRIES, INC.JIL2022-10-28
40612479183627McKessonMCKESSON MEDICAL-SURGICAL INC.JIL2022-07-28
10884389181973MedlineMEDLINE INDUSTRIES, INC.JIL2022-04-13
10884389181959MedlineMEDLINE INDUSTRIES, INC.JIL2021-09-16
00722066005255Rapid ResponseBTNX IncJIL2020-12-14
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10888277110403MedlineMEDLINE INDUSTRIES, INC.JIL2020-08-21
10885380175589CARDINAL HEALTHCardinal Health 200, LLCJIL2020-07-09
20885380175548CARDINAL HEALTHCardinal Health 200, LLCJIL2020-06-30
20885380175555CARDINAL HEALTHCardinal Health 200, LLCJIL2020-06-30
20885380175579CARDINAL HEALTHCardinal Health 200, LLCJIL2020-06-30
08806141302070CYBOW 10DFI CO.,LTDJIL2020-06-29