Carolina Liquid Chemistries Corp.® Etha Rgt. Kit St321

FDA UDI

Class II (US FDA UDI)

by Carolina Liquid Chemistries Corp.

Identity

Trade Name: CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST321 FDA UDI
Generic Name: Ethanol (ETOH) IVD, kit, spectrophotometry FDA UDI
Device Name: ETHA (Alcohol) w/ cal 2 x 300 tests FDA UDI
Model / Reference: ST321 FDA UDI
Description: ETHA (Alcohol) w/ cal 2 x 300 tests FDA UDI

Identifiers

Catalog Number: ST321 FDA UDI
Primary DI / UDI-DI: 00817302021363 FDA UDI
FDA Product Code: DNN FDA UDI
DIC FDA UDI
DKC FDA UDI
GMDN Term: Ethanol (ETOH) IVD, kit, spectrophotometry FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.3200 FDA UDI
862.3040 FDA UDI
862.3280 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 — 5 Milliliter FDA UDI
Total Volume — 33 Milliliter FDA UDI
Total Volume — 13 Milliliter FDA UDI

Category: Ethanol (ETOH) IVD, kit, spectrophotometry

Carolina Liquid Chemistries Corp.® Etha Rgt. Kit St321 by Carolina Liquid Chemistries Corp. — Class II — FDA UDI — listed in FDA GUDID

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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 022c9d73-06e1-4ee3-9add-05667a0ae643 37 fields · synced May 31, 2026