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Aimstep H. Pylori

FDA UDI

Class I (US FDA UDI)

by Germaine Laboratories, Inc.

Identity

Trade Name
AIMSTEP H. PYLORI FDA UDI
Generic Name
Helicobacter pylori antigen IVD, kit, rapid ICT, clinical FDA UDI
Device Name
A rapid cassette test for the qualitative detection of Helicobabacter pylori in serum, plasma, or whole blood. FDA UDI
Model / Reference
33020 FDA UDI
Description
A rapid cassette test for the qualitative detection of Helicobabacter pylori in serum, plasma, or whole blood. FDA UDI

Identifiers

Primary DI / UDI-DI
00695684330200 FDA UDI
FDA Product Code
LYR FDA UDI
GMDN Term
Helicobacter pylori antigen IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3110 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: Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

Aimstep H. Pylori by Germaine Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Helicobacter pylori antigen IVD, kit, rapid ICT, 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 97696f68-5303-4bfa-b426-d0b8bd0e2664 33 fields · synced May 30, 2026