Carolina Liquid Chemistries Corp.® Hcy Level 2 Control Kit Part# Cc052

FDA UDI

Class I (US FDA UDI)

by Carolina Liquid Chemistries Corp.

Identity

Trade Name: CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 2 CONTROL KIT PART# CC052 FDA UDI
Generic Name: Homocysteine IVD, control FDA UDI
Device Name: HCY (Homocysteine) Level 2 control 6 x 5 mL FDA UDI
Model / Reference: CC052 FDA UDI
Description: HCY (Homocysteine) Level 2 control 6 x 5 mL FDA UDI

Identifiers

Catalog Number: CC052 FDA UDI
Primary DI / UDI-DI: 00817302020106 FDA UDI
FDA Product Code: JJX FDA UDI
LPS FDA UDI
GMDN Term: Homocysteine IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
862.1377 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

Dimensions & Sizes

Size: Total Volume — 5 Milliliter FDA UDI

Category: Homocysteine IVD, control

Carolina Liquid Chemistries Corp.® Hcy Level 2 Control Kit Part# Cc052 by Carolina Liquid Chemistries Corp. — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Homocysteine IVD, control.

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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
Audit MicroControls Linearity LQ Homocysteine — Aalto Scientific, Ltd.
InteliQ — Bio-Rad Laboratories · Class I

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: Carolina Liquid Chemistries Corp.

Sources (1)

FDA UDI b3ad2757-83ab-4516-beb0-d8d7aeae82eb 37 fields · synced May 30, 2026