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UASure uric acid control solution

FDA UDI

Class I (US FDA UDI)

by Apex Biotechnology Corp.

Identity

Trade Name
UASure uric acid control solution FDA UDI
Generic Name
Uric acid IVD, control FDA UDI
Model / Reference
UAsure control solution FDA UDI

Identifiers

Primary DI / UDI-DI
04713648766486 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Uric acid 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Uric acid IVD, control

UASure uric acid control solution by Apex Biotechnology Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Uric acid IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Apex Biotechnology Corp.

Sources (1)

  • FDA UDI d8d595a8-d994-49aa-9c64-76baff8ed43e 32 fields · synced May 31, 2026