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UA-Cellular for UF

FDA UDI

Class II (US FDA UDI)

by Streck

Identity

Trade Name
UA-Cellular for UF FDA UDI
Generic Name
Urine sediment IVD, control FDA UDI
Device Name
Urinalysis control designed specifically for the Sysmex® UF-1000i™ urine analyzer. Contains 1 vial each of Level 1 & 2. FDA UDI
Model / Reference
213465 FDA UDI
Description
Urinalysis control designed specifically for the Sysmex® UF-1000i™ urine analyzer. Contains 1 vial each of Level 1 & 2. FDA UDI

Identifiers

Catalog Number
213465 FDA UDI
Primary DI / UDI-DI
00844509001997 FDA UDI
510(k) Number
K090201 FDA UDI
FDA Product Code
JPK FDA UDI
GMDN Term
Urine sediment IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.8625 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 — 45 Milliliter FDA UDI

Category: Urine sediment IVD, control

UA-Cellular for UF by Streck — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urine sediment IVD, control.

Cleared under the same submission

K090201 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Streck

Sources (1)

  • FDA UDI 33a0759a-df08-4681-985e-520da45a9b96 38 fields · synced May 30, 2026