Co2

FDA UDI

Class II (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name: CO2 FDA UDI
Generic Name: Bicarbonate (HCO3-) IVD, reagent FDA UDI
Device Name: The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma. FDA UDI
Model / Reference: CD127 FDA UDI
Description: The device is intended for the quantitative in vitro determination of carbon dioxide in serum or plasma. FDA UDI

Identifiers

Catalog Number: CD127 FDA UDI
Primary DI / UDI-DI: 05055273201024 FDA UDI
510(k) Number: K951221 FDA UDI
FDA Product Code: KHS FDA UDI
GMDN Term: Bicarbonate (HCO3-) IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1160 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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: Bicarbonate (HCO3-) IVD, reagent

Co2 by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bicarbonate (HCO3-) IVD, reagent.

Piccolo Basic Metabolic Panel — ABAXIS, INC. · Class II
Piccolo Comprehensive Metabolic Panel — ABAXIS, INC. · Class II
Piccolo Electrolyte Panel — ABAXIS, INC. · Class II
Piccolo MetLyte 8 Panel — ABAXIS, INC. · Class II
Piccolo MetLac 12 Panel — ABAXIS, INC. · Class I
Piccolo Basic Metabolic Panel Plus — ABAXIS, INC. · Class II
Piccolo MetLyte Plus CRP — ABAXIS, INC. · Class II
Piccolo Renal Function Panel — ABAXIS, INC. · Class I

Cleared under the same submission

K951221 also covers:

CO2 — Randox Laboratories, Ltd.
LCO2-2 — Randox Laboratories, Ltd.

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: Randox Laboratories, Ltd.

Sources (1)

FDA UDI a41cdf9e-77d9-45a2-9cf9-a43c1cb5ed83 37 fields · synced May 30, 2026