Identity
- Trade Name
- Helicobacter pylori FDA UDI
- Generic Name
- Helicobacter pylori antigen IVD, kit, enzyme immunohistochemistry FDA UDI
- Model / Reference
- CM383A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847627007278 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Helicobacter pylori antigen IVD, kit, enzyme immunohistochemistry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
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, enzyme immunohistochemistry
Helicobacter pylori by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Helicobacter pylori antigen IVD, kit, enzyme immunohistochemistry.
- Helicobacter pylori — BIOCARE MEDICAL, LLC · Class I
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 |
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Manufacturer
- Manufacturer
- Biocare Medical, Llc
Sources (1)
- FDA UDI 8510ec06-ecd4-4cfc-a623-de2edfd13a7a 33 fields · synced May 30, 2026