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CAROLINA LIQUID CHEMISTRIES CORP.™ Lp(a)-d LIPOPROTEIN A CC204-100-D

FDA UDI

Class II (US FDA UDI)

by Carolina Liquid Chemistries Corp.

Identity

Trade Name
CAROLINA LIQUID CHEMISTRIES CORP.™ Lp(a)-d LIPOPROTEIN A CC204-100-D FDA UDI
Generic Name
LDL (low density lipoprotein) antibody (anti-LDL) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Lp(a) (Lipoprotein (a) 2 x 60 tests FDA UDI
Model / Reference
CC204-100-D FDA UDI
Description
Lp(a) (Lipoprotein (a) 2 x 60 tests FDA UDI

Identifiers

Catalog Number
CC204-100-D FDA UDI
Primary DI / UDI-DI
00817302020151 FDA UDI
FDA Product Code
DFC FDA UDI
JIT FDA UDI
JJX FDA UDI
GMDN Term
LDL (low density lipoprotein) antibody (anti-LDL) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5600 FDA UDI
862.1150 FDA UDI
862.1660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 4 Milliliter FDA UDI
Total Volume — 15 Milliliter FDA UDI

Category: LDL (low density lipoprotein) antibody (anti-LDL) IVD, kit, enzyme immunoassay (EIA)

CAROLINA LIQUID CHEMISTRIES CORP.™ Lp(a)-d LIPOPROTEIN A CC204-100-D by Carolina Liquid Chemistries Corp. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as LDL (low density lipoprotein) antibody (anti-LDL) IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Carolina Liquid Chemistries Corp.

Sources (1)

  • FDA UDI 6d9f7b3a-f066-44fb-b866-4c23577cf40e 37 fields · synced May 30, 2026