Bun Rate Reagent

FDA UDI

Class II (US FDA UDI)

by Cliniqa Corporation

Identity

Trade Name: Bun Rate Reagent FDA UDI
Generic Name: Urea IVD, reagent FDA UDI
Device Name: Bun Rate Reagent FDA UDI
Model / Reference: R82043 FDA UDI
Description: Bun Rate Reagent FDA UDI

Identifiers

Primary DI / UDI-DI: 00817238010820 FDA UDI
510(k) Number: K012649 FDA UDI
FDA Product Code: CDQ FDA UDI
GMDN Term: Urea IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1770 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

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: Urea IVD, reagent

Bun Rate Reagent by Cliniqa Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urea IVD, reagent.

Teco Diagnostics Urea Nitrogen (BUN) Reagent Set (Colorimetric Method) — TECO DIAGNOSTICS · Class II
Piccolo Basic Metabolic Panel — ABAXIS, INC. · Class II
Teco Diagnostics Urea Nitrogen (BUN) Reagent Set — TECO DIAGNOSTICS · Class II
i-STAT — Abbott Point of Care Inc. · Class II
Piccolo Comprehensive Metabolic Panel — ABAXIS, INC. · Class II
UREA — Randox Laboratories, Ltd. · Class II
ARCHITECT — Abbott · Class II
ARCHITECT — Abbott · Class II

Cleared under the same submission

K012649 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 II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Cliniqa Corporation

Sources (1)

FDA UDI b4fe56b6-f542-46ad-bd6c-300ced8f5a0b 34 fields · synced May 30, 2026