Identity
- Trade Name
- Serim® PyloriTek® Test Kit FDA UDI
- Generic Name
- Helicobacter pylori urease IVD, kit, chromogenic FDA UDI
- Device Name
- The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the presumptive identification of Helicobacter pylori. FDA UDI
- Model / Reference
- 05140K FDA UDI
- Description
- The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the presumptive identification of Helicobacter pylori. FDA UDI
Identifiers
- Catalog Number
- 05140K FDA UDI
- Primary DI / UDI-DI
- M1745140K1 FDA UDI
- 510(k) Number
- K953632 FDA UDI
- FDA Product Code
- LYR FDA UDI
- GMDN Term
- Helicobacter pylori urease IVD, kit, chromogenic 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 urease IVD, kit, chromogenic
Serim® PyloriTek® Test Kit by Serim Research Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Helicobacter pylori urease IVD, kit, chromogenic.
- BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) — Otsuka America Pharmaceutical Inc · Class III
- Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA — Otsuka America Pharmaceutical Inc · Class III
- BreathTek UBT for H. pylori — MERIDIAN BIOSCIENCE, INC. · Class III
- BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit) — Otsuka America Pharmaceutical Inc · Class III
- PyloPlus+ Rapid Urease Test — Arj Medical, Inc. · Class I
- Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA — MERIDIAN BIOSCIENCE, INC. · Class III
- Serim® PyloriTek® Test Kit — SERIM RESEARCH CORP. · Class I
Cleared under the same submission
K953632 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
- Serim Research Corp.
Sources (1)
- FDA UDI b3f89921-9db5-4b95-bfa5-a0baba6fd881 37 fields · synced May 30, 2026