Identity
- Trade Name
- IMMULITE® Systems HPG CONTROL H.pylori IgG FDA UDI
- Generic Name
- Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control FDA UDI
- Device Name
- H.Pylori - IMMULITE - CTL FDA UDI
- Model / Reference
- 10469596 FDA UDI
- Description
- H.Pylori - IMMULITE - CTL FDA UDI
Identifiers
- Catalog Number
- LHPGCM FDA UDI
- Primary DI / UDI-DI
- 00630414989907 FDA UDI
- 510(k) Number
- K000463 FDA UDI
- FDA Product Code
- LYR FDA UDI
- GMDN Term
- Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control 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, control
IMMULITE® Systems HPG CONTROL H.pylori IgG by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control.
- LIAISON® H. pylori IgG Control Set — Diasorin Inc.
- Liquichek — Bio-Rad Laboratories · Class I
- Helicobacter Pylori control slides — BIO SB, INC. · Class I
- PyloriTrol — Bio-Rad Laboratories · Class I
- Liquichek — Bio-Rad Laboratories · Class I
- Helicobacter pylori control slides — BIO SB, INC. · Class I
- Helicobacter Pylori control slides — BIO SB, INC. · Class I
- Liquichek — Bio-Rad Laboratories · Class I
Cleared under the same submission
K000463 also covers:
- IMMULITE® 1000 System ID2 DIL ID2 Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® 2000 Systems HPG H.pylori IgG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® 2000 Systems HPG H.pylori IgG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®/IMMULITE® 1000 Systems HPG H.pylori IgG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 0951dfc8-f3c9-4282-be5e-af85d666d1e7 37 fields · synced Jun 1, 2026