← Back to catalogue

INSTANT-VIEW H. pylori Rapid Test

FDA UDI

Class I (US FDA UDI)

by Alfa Scientific Designs, Inc.

Identity

Trade Name
INSTANT-VIEW H. pylori Rapid Test FDA UDI
Generic Name
Helicobacter pylori antigen IVD, kit, rapid ICT, clinical FDA UDI
Device Name
INSTANT-VIEW H. pylori Rapid Test FDA UDI
Model / Reference
05-9475 FDA UDI
Description
INSTANT-VIEW H. pylori Rapid Test FDA UDI

Identifiers

Primary DI / UDI-DI
10796918001839 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

No

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: Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

INSTANT-VIEW H. pylori Rapid Test by Alfa Scientific Designs, 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

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

Manufacturer

Manufacturer
Alfa Scientific Designs, Inc.

Sources (1)

  • FDA UDI 3ebdee5c-446c-4746-b59d-f2a2bca6f342 33 fields · synced Jun 9, 2026