Identity
- Trade Name
- Urease FDA UDI
- Generic Name
- Helicobacter pylori urease IVD, control FDA UDI
- Device Name
- Urease Glycerol Solution FDA UDI
- Model / Reference
- GIS-62-2ML FDA UDI
- Description
- Urease Glycerol Solution FDA UDI
Identifiers
- Catalog Number
- GIS-62-2ML FDA UDI
- Primary DI / UDI-DI
- 00893029002571 FDA UDI
- 510(k) Number
- K012411 FDA UDI
- FDA Product Code
- LYR FDA UDI
- GMDN Term
- Helicobacter pylori urease 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Helicobacter pylori urease IVD, control
Urease by GI Supply, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K012411 also covers:
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
- GI Supply, Inc.
Sources (1)
- FDA UDI 201b0a69-12d5-4def-9070-830594f8b6e1 37 fields · synced May 30, 2026