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Detector UA 2

FDA UDI

Class I (US FDA UDI)

by Immunostics, Inc.

Identity

Trade Name
Detector UA 2 FDA UDI
Generic Name
Urine glucose IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several different reagent areas are affixed FDA UDI
Model / Reference
IDU-2PG FDA UDI
Description
Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several different reagent areas are affixed FDA UDI

Identifiers

Primary DI / UDI-DI
10722355002245 FDA UDI
510(k) Number
K955438 FDA UDI
FDA Product Code
JIR FDA UDI
JIL FDA UDI
GMDN Term
Urine glucose IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1645 FDA UDI
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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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, clinicalUrine protein IVD, kit, rapid colorimetric, clinical

Detector UA 2 by Immunostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K955438 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Immunostics, Inc.

Sources (1)

  • FDA UDI 17bdf112-a948-4e2c-b07e-89a2e984ab6a 36 fields · synced May 30, 2026