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Hp Detect™ Stool Antigen ELISA
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 7083
Identity
- Trade Name
- Hp Detect™ Stool Antigen ELISA EUDAMEDHp Detect Stool Antigen ELISA FDA UDI
- Generic Name
- Helicobacter pylori antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- HP Detect Stool Antigen ELISA EUDAMEDThe Hp Detect™ Stool Antigen ELISA is an in vitro diagnostic qualitative enzyme immunoassay for the detection of Helicobacter pylori (H. pylori) antigens in human stool or feces. The Hp Detect™ Stool Antigen ELISA is intended to aid in the initial diagnosis and post-therapy diagnosis of H. pylori infection. Additionally, the test may be used to assess H. pylori infection status after treatment. Retesting at a minimum of 4 weeks after the completion of treatment may be done to assess H. pylori status. Test results should always be taken into consideration by the physician in conjunction with patient’s clinical information (history and symptoms). For Prescription Use Only. FDA UDI
- Model / Reference
- 7083 EUDAMEDFDA UDI
- Description
- The Hp Detect™ Stool Antigen ELISA is an in vitro diagnostic qualitative enzyme immunoassay for the detection of Helicobacter pylori (H. pylori) antigens in human stool or feces. The Hp Detect™ Stool Antigen ELISA is intended to aid in the initial diagnosis and post-therapy diagnosis of H. pylori infection. Additionally, the test may be used to assess H. pylori infection status after treatment. Retesting at a minimum of 4 weeks after the completion of treatment may be done to assess H. pylori status. Test results should always be taken into consideration by the physician in conjunction with patient’s clinical information (history and symptoms). For Prescription Use Only. FDA UDI
Identifiers
- Catalog Number
- 7083 FDA UDI
- Primary DI / UDI-DI
- 00083059070835 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00083059070835 EUDAMED
- 510(k) Number
- K232892 FDA UDI
- FDA Product Code
- LYR FDA UDI
- EMDN Code
- W0105010401 H. PYLORI ANTIGEN DETECTION EUDAMED
- GMDN Term
- Helicobacter pylori antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 866.3110 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
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
Hp Detect™ Stool Antigen ELISA by Biomerica, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00083059070835 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Biomerica, Inc.
- EUDAMED SRN
- US-MF-000015772
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 3c7a9475-05a9-439f-a945-19985251824c 61 fields · synced Jun 18, 2026
- FDA UDI 29001fa0-7893-419f-9301-99b9e8bb2fde 35 fields · synced May 30, 2026