Dipper Urinalysis Dipstick Control Level 1&2 Set 6x15mL

FDA UDI

Class I (US FDA UDI)

by Quantimetrix Corp.

Identity

Trade Name: Dipper Urinalysis Dipstick Control Level 1&2 Set 6x15mL FDA UDI
Generic Name: Multiple urine analyte IVD, control FDA UDI
Device Name: The Dipper 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 supplied in two levels as 6x15mL, three tubes of each level or 6x15mL level 2 only. 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: 1440-01 FDA UDI
Description: The Dipper 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 supplied in two levels as 6x15mL, three tubes of each level or 6x15mL level 2 only. 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: 1440-01 FDA UDI
Primary DI / UDI-DI: 00896863002134 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Multiple urine analyte IVD, control

Dipper Urinalysis Dipstick Control Level 1&2 Set 6x15mL 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:

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 823a41f1-6f46-4075-9ccf-d6d750e0bc6c 37 fields · synced May 29, 2026