Carolina Liquid Chemistries Corp.® Crp-W Control Set Cc049

FDA UDI

Class II (US FDA UDI)

by Carolina Liquid Chemistries Corp.

Identity

Trade Name: CAROLINA LIQUID CHEMISTRIES CORP.® CRP-W CONTROL SET CC049 FDA UDI
Generic Name: Glucose IVD, control FDA UDI
Device Name: CRPhsWR (C-Reactive Protein high sensitivity Wide Range) control FDA UDI
Model / Reference: CC049 FDA UDI
Description: CRPhsWR (C-Reactive Protein high sensitivity Wide Range) control FDA UDI

Identifiers

Catalog Number: CC049 FDA UDI
Primary DI / UDI-DI: 00817302022100 FDA UDI
510(k) Number: K002651 FDA UDI
FDA Product Code: DCK FDA UDI
JIS FDA UDI
GMDN Term: Glucose IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.5270 FDA UDI
862.1150 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

Yes

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 — 3 Milliliter FDA UDI

Category: Glucose IVD, control

Carolina Liquid Chemistries Corp.® Crp-W Control Set Cc049 by Carolina Liquid Chemistries Corp. — Class II — FDA UDI — listed in FDA GUDID

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Cleared under the same submission

K002651 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

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Manufacturer

Manufacturer: Carolina Liquid Chemistries Corp.

Sources (1)

FDA UDI a2feada1-e8ac-48f3-9734-d407e374fd47 38 fields · synced May 31, 2026