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UA-Cellular Complete

FDA UDI

Class I (US FDA UDI)

by Streck

Identity

Trade Name
UA-Cellular Complete FDA UDI
Generic Name
Urine sediment IVD, control FDA UDI
Device Name
A comprehensive cellular component and chemistry analyte urinalysis control designed specifically for the Siemens CLINITEK Atlas® and Sysmex® UF-1000i™ combined urinalysis system. Contains 1 vial each of L-PC,PCM & NC. FDA UDI
Model / Reference
218991 FDA UDI
Description
A comprehensive cellular component and chemistry analyte urinalysis control designed specifically for the Siemens CLINITEK Atlas® and Sysmex® UF-1000i™ combined urinalysis system. Contains 1 vial each of L-PC,PCM & NC. FDA UDI

Identifiers

Catalog Number
218991 FDA UDI
Primary DI / UDI-DI
00844509001935 FDA UDI
510(k) Number
K131444 FDA UDI
FDA Product Code
JJW 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

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

Dimensions & Sizes

Size
Total Volume — 120 Milliliter FDA UDI

Category: Urine sediment IVD, control

UA-Cellular Complete by Streck — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urine sediment IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Streck

Sources (1)

  • FDA UDI 974be02d-20ed-4fd2-9c29-c8a2a8473b1d 38 fields · synced May 30, 2026