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Carolina Liquid Chemistries Corp.® Cyst Cystatin Cc691

FDA UDI

Class II (US FDA UDI)

by Carolina Liquid Chemistries Corp.

Identity

Trade Name
CAROLINA LIQUID CHEMISTRIES CORP.® CYST CYSTATIN CC691 FDA UDI
Generic Name
Cystatin C IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
CYST (Cystatin-C) 2 x 100 tests FDA UDI
Model / Reference
CC691 FDA UDI
Description
CYST (Cystatin-C) 2 x 100 tests FDA UDI

Identifiers

Catalog Number
CC691 FDA UDI
Primary DI / UDI-DI
00817302020069 FDA UDI
FDA Product Code
NDY FDA UDI
JIT FDA UDI
JJX FDA UDI
GMDN Term
Cystatin C IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1225 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 — 4.5 Milliliter FDA UDI
Total Volume — 20 Milliliter FDA UDI

Category: Cystatin C IVD, kit, enzyme immunoassay (EIA)

Carolina Liquid Chemistries Corp.® Cyst Cystatin Cc691 by Carolina Liquid Chemistries Corp. — Class II — FDA UDI — listed in FDA GUDID

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 4ad9451a-b8c3-4536-832f-ec436ece12ba 37 fields · synced Jun 6, 2026