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Aimstrip Us-N

FDA UDI

Class I (US FDA UDI)

by Germaine Laboratories, Inc.

Identity

Trade Name
AIMSTRIP US-N FDA UDI
Generic Name
Urine nitrite IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
Dipstick reagent strips for the qualitative detection of Nitrite in Urine. FDA UDI
Model / Reference
50131 FDA UDI
Description
Dipstick reagent strips for the qualitative detection of Nitrite in Urine. FDA UDI

Identifiers

Primary DI / UDI-DI
00695684501310 FDA UDI
FDA Product Code
JMT FDA UDI
KQO FDA UDI
GMDN Term
Urine nitrite IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1510 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

Yes

FDA UDI

Over-the-Counter

No

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 nitrite IVD, kit, rapid colorimetric, clinical

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

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Germaine Laboratories, Inc.

Sources (1)

  • FDA UDI a055c400-897b-48ca-9a09-318f5a7436be 33 fields · synced May 31, 2026