← Back to catalogue

Aimstrip Us-K

FDA UDI

Class I (US FDA UDI)

by Germaine Laboratories, Inc.

Identity

Trade Name
AIMSTRIP US-K FDA UDI
Generic Name
Urine ketone IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
Dipstick reagent strips for the qualitative detection of Ketone in Urine. FDA UDI
Model / Reference
50121 FDA UDI
Description
Dipstick reagent strips for the qualitative detection of Ketone in Urine. FDA UDI

Identifiers

Primary DI / UDI-DI
00695684501211 FDA UDI
FDA Product Code
JIN FDA UDI
KQO FDA UDI
GMDN Term
Urine ketone IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1435 FDA UDI
862.2900 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 ketone IVD, kit, rapid colorimetric, clinical

Aimstrip Us-K by Germaine Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Germaine Laboratories, Inc.

Sources (1)

  • FDA UDI 4ca260d5-d3dd-465b-aced-7b0095b8782e 33 fields · synced May 31, 2026