Axis-Shield Homocysteine Controls

FDA UDI

Class I (US FDA UDI)

by Axis-Shield Diagnostics Limited

Identity

Trade Name: Axis-Shield Homocysteine Controls FDA UDI
Generic Name: Homocysteine IVD, control FDA UDI
Device Name: The Axis-Shield Homocysteine Control Kit is intended to be used as an assayed quality control serum when used for the quantitative measurement of total L-homocysteine in human serum or plasma. FDA UDI
Model / Reference: FHCY200 FDA UDI
Description: The Axis-Shield Homocysteine Control Kit is intended to be used as an assayed quality control serum when used for the quantitative measurement of total L-homocysteine in human serum or plasma. FDA UDI

Identifiers

Catalog Number: FHCY200 FDA UDI
Primary DI / UDI-DI: 05055845400022 FDA UDI
510(k) Number: K980907 FDA UDI
FDA Product Code: JJX FDA UDI
DFC FDA UDI
GMDN Term: Homocysteine IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
866.5600 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

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: Homocysteine IVD, control

Axis-Shield Homocysteine Controls by Axis-Shield Diagnostics Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Homocysteine IVD, control.

CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 1 CONTROL KIT PART# CC051 — Carolina Liquid Chemistries Corp. · Class II
CAROLINA LIQUID CHEMISTRIES CORP.™ HCY HOMOCYSTEINE REAGENT CC202 — Carolina Liquid Chemistries Corp. · Class II
Liquichek — Bio-Rad Laboratories · Class I
Audit MicroControls Control LQ Homocysteine — Aalto Scientific, Ltd. · Class I
Plasma Control Bi-Level — Chromsystems Instruments & Chemicals GmbH · Class I
ARCHITECT — Abbott · Class II
InteliQ — Bio-Rad Laboratories · Class I
ADVIA Centaur® HCY MCM — Siemens Healthcare Diagnostics · Class I

Cleared under the same submission

K980907 also covers:

Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.

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 I	Pending data

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Manufacturer

Manufacturer: Axis-Shield Diagnostics Limited

Sources (1)

FDA UDI 4f971af8-835d-4596-b55a-faba4cd1e822 37 fields · synced May 30, 2026