Identity
- Trade Name
- TECO DIAGNOSTICS FDA UDI
- Generic Name
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- TECO DIAGNOSTICS URS-2K-100GL BOTTLE WITH LABEL FDA UDI
- Model / Reference
- URS-2K-100GL BOTTLE WITH LABEL FDA UDI
- Description
- TECO DIAGNOSTICS URS-2K-100GL BOTTLE WITH LABEL FDA UDI
Identifiers
- Catalog Number
- URS-2K-100GL FDA UDI
- Primary DI / UDI-DI
- 10673486000641 FDA UDI
- 510(k) Number
- K970250 FDA UDI
- FDA Product Code
- JIN FDA UDIJIL FDA UDI
- GMDN Term
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1435 FDA UDI862.1340 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
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
Category: Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Teco Diagnostics by Teco Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple urine analyte IVD, kit, rapid colorimetric, clinical.
- Mission Urinalysis Reagent Strips — ACON Laboratories, Inc. · Class I
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- Mission Urinalysis Reagent Strips — ACON Laboratories, Inc. · Class I
- Mission Urinalysis Reagent Strips — ACON Laboratories, Inc. · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- Moore Medical — Moore Medical Corp. · Class I
- InstaTest — Diagnostic Automation, Inc. · Class I
- Mission Urinalysis Reagent Strips — ACON Laboratories, Inc. · Class II
Cleared under the same submission
K970250 also covers:
- Detector UA 10 — IMMUNOSTICS, INC.
- Detector UA 5 — IMMUNOSTICS, INC.
- Urine Reagent Strips, 10-parameter — LW SCIENTIFIC, INC.
- Urine Reagent Strips, 5-parameter — LW SCIENTIFIC, INC.
- TECO DIAGNOSTICS — TECO DIAGNOSTICS
- TECO DIAGNOSTICS — TECO DIAGNOSTICS
- TECO DIAGNOSTICS — TECO DIAGNOSTICS
- TECO DIAGNOSTICS — TECO DIAGNOSTICS
- TECO DIAGNOSTICS — TECO DIAGNOSTICS
- TECO DIAGNOSTICS — TECO DIAGNOSTICS
- TECO DIAGNOSTICS — TECO DIAGNOSTICS
- TECO DIAGNOSTICS — TECO DIAGNOSTICS
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
- Teco Diagnostics
Sources (1)
- FDA UDI 5fdbbee4-7f59-49c0-a402-521b3798a109 35 fields · synced May 31, 2026