← Back to catalogue
Dropper Urine Chemistry Control Level 1&2 Set 2x10mL
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Dropper Urine Chemistry Control Level 1&2 Set 2x10mL FDA UDI
- Generic Name
- Multiple urine analyte IVD, control FDA UDI
- Device Name
- The Dropper Urine Chemistry Control is intended for use as a control for human urine assay methods. It is supplied as a ready-to-use liquid requiring no reconstitution. They are prepared from human urine and fortified to target levels with human proteins and reagent grade chemicals. Preservatives have been added to inhibit microbial growth. FDA UDI
- Model / Reference
- 1430-01 FDA UDI
- Description
- The Dropper Urine Chemistry Control is intended for use as a control for human urine assay methods. It is supplied as a ready-to-use liquid requiring no reconstitution. They are prepared from human urine and fortified to target levels with human proteins and reagent grade chemicals. Preservatives have been added to inhibit microbial growth. FDA UDI
Identifiers
- Catalog Number
- 1430-01 FDA UDI
- Primary DI / UDI-DI
- 00896863002189 FDA UDI
- 510(k) Number
- K831526 FDA UDI
- FDA Product Code
- JJW FDA UDI
- GMDN Term
- Multiple urine analyte IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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, control
Dropper Urine Chemistry Control Level 1&2 Set 2x10mL by Quantimetrix Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple urine analyte IVD, control.
- URINALYSIS CONTROL - LEVEL 2 (URNAL CONTROL 2) — Randox Laboratories, Ltd. · Class I
- Mission Liquid Urine Controls — ACON Laboratories, Inc. · Class I
- Urine Chemistry Control Bi-Level — CLINIQA CORPORATION · Class I
- iChem® VELOCITY™ — BECKMAN COULTER IRELAND INC. · Class I
- ABX PENTRA URINE CONTROL L/H — Horiba Abx · Class I
- K-ASSAY® Microalbumin Urine Control — KAMIYA BIOMEDICAL COMPANY, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- qUAntify — Bio-Rad Laboratories · Class I
Cleared under the same submission
K831526 also covers:
- Pointe Scientific, Inc. Microalbumin Controls — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Urine Chemistry Controls — POINTE SCIENTIFIC, INC.
- Dropper Urine Chemistry Control Level 1 Set 3x10mL — QUANTIMETRIX CORP.
- Dropper Urine Chemistry Control Level 1 Set 3x25mL — QUANTIMETRIX CORP.
- Dropper Urine Chemistry Control Level 2 Set 3x10mL — QUANTIMETRIX CORP.
- Dropper Urine Chemistry Control Level 2 Set 3x25mL — QUANTIMETRIX CORP.
- Microbumin Microalbumin Control Level 1&2 Set 10x7mL — QUANTIMETRIX CORP.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Quantimetrix Corp.
Sources (1)
- FDA UDI c7291c89-8f9f-4b2a-b152-79fb89c110b9 37 fields · synced May 30, 2026