Dip&Spin Urinalysis Dipstick and Microscopics Control Level 1&2 Set 4x120mL

FDA UDI

Class I (US FDA UDI)

by Quantimetrix Corp.

Identity

Trade Name: Dip&Spin Urinalysis Dipstick and Microscopics Control Level 1&2 Set 4x120mL FDA UDI
Generic Name: Urine sediment IVD, control FDA UDI
Device Name: The Dip&Spin Urinalysis Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed methods, and as a control for confirmatory tests. It is also intended as a means of validating the processing and centrifugation of patient urine samples prior to microscopic evaluation of urine sediment. The controls are supplied liquid, ready-to-use in two levels. They do not require reconstitution or dilution. They are prepared from human urine to which stabilized human red and white blood cells, calcium oxalate crystals, and other compounds have been added to produce the desired reactions when tested by methods described in the product insert. FDA UDI
Model / Reference: 1470-01 FDA UDI
Description: The Dip&Spin Urinalysis Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed methods, and as a control for confirmatory tests. It is also intended as a means of validating the processing and centrifugation of patient urine samples prior to microscopic evaluation of urine sediment. The controls are supplied liquid, ready-to-use in two levels. They do not require reconstitution or dilution. They are prepared from human urine to which stabilized human red and white blood cells, calcium oxalate crystals, and other compounds have been added to produce the desired reactions when tested by methods described in the product insert. FDA UDI

Identifiers

Catalog Number: 1470-01 FDA UDI
Primary DI / UDI-DI: 00896863002172 FDA UDI
510(k) Number: K874890 FDA UDI
K925256 FDA UDI
FDA Product Code: JJY FDA UDI
GMDN Term: Urine sediment 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 Urine sediment IVD, control

Dip&Spin Urinalysis Dipstick and Microscopics Control Level 1&2 Set 4x120mL by Quantimetrix Corp. — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Urine sediment IVD, control.

Cleared under the same submission

K874890 also covers:

K925256 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 782f0524-3e4a-4283-af8c-f4685bdc0a17 37 fields · synced May 30, 2026