← Back to catalogue

IMMULITE® 2000 Systems HPG H.pylori IgG

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
IMMULITE® 2000 Systems HPG H.pylori IgG FDA UDI
Generic Name
Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
Helicobacter pylori IgG Ab - IMMULITE - RGT - 600 Tests FDA UDI
Model / Reference
10381335 FDA UDI
Description
Helicobacter pylori IgG Ab - IMMULITE - RGT - 600 Tests FDA UDI

Identifiers

Catalog Number
L2KHPG6 FDA UDI
Primary DI / UDI-DI
00630414961644 FDA UDI
510(k) Number
K000463 FDA UDI
FDA Product Code
LYR FDA UDI
GMDN Term
Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay 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

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 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems HPG H.pylori IgG by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

K000463 also covers:

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
Siemens Healthcare Diagnostics Products Ltd

Sources (1)

  • FDA UDI 420a52dd-a747-440a-bfd6-f0f66332ea5c 37 fields · synced May 30, 2026