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Diastix®

FDA UDI

Class II (US FDA UDI)

by Ascensia Diabetes Care Us Inc.

Identity

Trade Name
DIASTIX® FDA UDI
Generic Name
Urine glucose IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
Reagent strips for urinalysis - glucose. 50 test strips. FDA UDI
Model / Reference
2806 FDA UDI
Description
Reagent strips for urinalysis - glucose. 50 test strips. FDA UDI

Identifiers

Catalog Number
8488841 FDA UDI
Primary DI / UDI-DI
10301932806508 FDA UDI
510(k) Number
K831600 FDA UDI
FDA Product Code
JIL FDA UDI
GMDN Term
Urine glucose IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1340 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Urine glucose IVD, kit, rapid colorimetric, clinical

Diastix® by Ascensia Diabetes Care Us Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urine glucose IVD, kit, rapid colorimetric, clinical.

Cleared under the same submission

K831600 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ascensia Diabetes Care Us Inc.

Sources (1)

  • FDA UDI f2624764-af8b-474a-8322-6870d6cfed84 37 fields · synced Jun 8, 2026