QuanTscopics Control Level 1 Set 4x120mL

FDA UDI

Class I (US FDA UDI)

by Quantimetrix Corp.

Identity

Trade Name: QuanTscopics Control Level 1 Set 4x120mL FDA UDI
Generic Name: Urine sediment IVD, control FDA UDI
Device Name: The QuanTscopics Urinalysis Microscopics Control is intended for use as quality control material for the microscopic evaluation of various urine sediment methods. It is supplied in two level, 4x120mL bottles per level per box. It is liquid, ready-to-use, requiring no reconstitution or dilution. The control is made from human urine to which stabilized human red blood cells, human white blood cells, and uric acid, calcium oxalate, and calcium phosphate crystals have been added. FDA UDI
Model / Reference: 1481-41 FDA UDI
Description: The QuanTscopics Urinalysis Microscopics Control is intended for use as quality control material for the microscopic evaluation of various urine sediment methods. It is supplied in two level, 4x120mL bottles per level per box. It is liquid, ready-to-use, requiring no reconstitution or dilution. The control is made from human urine to which stabilized human red blood cells, human white blood cells, and uric acid, calcium oxalate, and calcium phosphate crystals have been added. FDA UDI

Identifiers

Catalog Number: 1481-41 FDA UDI
Primary DI / UDI-DI: 00896863002264 FDA UDI
510(k) Number: 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

QuanTscopics Control Level 1 Set 4x120mL by Quantimetrix Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urine sediment IVD, control.

Cleared under the same submission

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 99a1aa01-f08d-449c-97d6-5a844935c802 37 fields · synced May 29, 2026