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Dropper Urinalysis Dipstick Control Level 1&2 Set 2x25mL
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Dropper Urinalysis Dipstick Control Level 1&2 Set 2x25mL FDA UDI
- Generic Name
- Multiple urine analyte IVD, control FDA UDI
- Device Name
- The Dropper Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests. They are liquid, ready-to-use requiring no reconstitution or dilution. They are prepared from human urine fortified to target levels with compounds that produce the desired reaction when tested by the methods indicated in the product insert. Preservatives have been added to inhibit microbial growth. FDA UDI
- Model / Reference
- 1440-03 FDA UDI
- Description
- The Dropper Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests. They are liquid, ready-to-use requiring no reconstitution or dilution. They are prepared from human urine fortified to target levels with compounds that produce the desired reaction when tested by the methods indicated in the product insert. Preservatives have been added to inhibit microbial growth. FDA UDI
Identifiers
- Catalog Number
- 1440-03 FDA UDI
- Primary DI / UDI-DI
- 00896863002127 FDA UDI
- 510(k) Number
- K874890 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 Urinalysis Dipstick Control Level 1&2 Set 2x25mL 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
K874890 also covers:
- Dip&Spin Urinalysis Dipstick and Microscopics Control Level 1&2 Set 2x25mL — QUANTIMETRIX CORP.
- Dip&Spin Urinalysis Dipstick and Microscopics Control Level 1&2 Set 4x120mL — QUANTIMETRIX CORP.
- Dipper Urinalysis Dipstick Control Level 1&2 Set 6x15mL — QUANTIMETRIX CORP.
- Dipper Urinalysis Dipstick Control Level 2 Set 6x15mL — QUANTIMETRIX CORP.
- Dropper Plus Point-of-Care Urinalysis Dipstick Control Level 1&2 Set 10x5mL — QUANTIMETRIX CORP.
- Dropper Plus Point-of-Care Urinalysis Dipstick Control Level 1&2 Set 2x5mL — QUANTIMETRIX CORP.
- Dropper Urinalysis Dipstick Control Level 1&2 Set 4x25mL — 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 |
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Manufacturer
- Manufacturer
- Quantimetrix Corp.
Sources (1)
- FDA UDI 7e300820-8e59-4f27-8352-e9565f8d9feb 37 fields · synced Jun 8, 2026