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Hp-Fast

FDA 510(k)FDA UDI

Class I (US FDA 510(k))

510(k) K944903

by Gi Supply

Identity

Trade Name
HpFast FDA UDI
Generic Name
Helicobacter pylori urease IVD, reagent FDA UDI
Device Name
HpFast detects the urease enzyme for the presumptive identification of Helicobacter pylori gastric mucosal biopsies. It is intended for in-vitro diagnostic use only. FDA UDI
Model / Reference
GIS-22 FDA UDI
Description
HpFast detects the urease enzyme for the presumptive identification of Helicobacter pylori gastric mucosal biopsies. It is intended for in-vitro diagnostic use only. FDA UDI

Identifiers

Catalog Number
GIS-22 FDA UDI
Primary DI / UDI-DI
00893029002519 FDA UDI
510(k) Number
K944903 FDA 510(k)FDA UDI
FDA Product Code
LYR FDA 510(k)FDA UDI
GMDN Term
Helicobacter pylori urease IVD, reagent FDA UDI

Classification

Device Class
Class I FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 866.3110 FDA 510(k)
Regulation Number
866.3110 FDA 510(k)FDA UDI
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

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

Yes

FDA UDI

Hp-Fast by Gi Supply — Class I — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Gi Supply

Sources (2)

  • FDA 510(k) K944903 24 fields · synced Jun 18, 2026
  • FDA UDI 1bdc574b-d541-478e-b5f9-9cc34c5aabab 37 fields · synced May 27, 2026