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CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c RGT. KIT BL-300

FDA UDI

Class II (US FDA UDI)

by Carolina Liquid Chemistries Corp.

Identity

Trade Name
CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c RGT. KIT BL-300 FDA UDI
Generic Name
Free plasma haemoglobin IVD, kit, enzyme immunohistochemistry FDA UDI
Device Name
HbA1c (Hemoglobin A1c Direct) 2 x 100 tests FDA UDI
Model / Reference
BL300 FDA UDI
Description
HbA1c (Hemoglobin A1c Direct) 2 x 100 tests FDA UDI

Identifiers

Catalog Number
BL300 FDA UDI
Primary DI / UDI-DI
00817302022155 FDA UDI
FDA Product Code
LCP FDA UDI
GMDN Term
Free plasma haemoglobin IVD, kit, enzyme immunohistochemistry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7470 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 — 10 Milliliter FDA UDI
Total Volume — 25 Milliliter FDA UDI

Category: Free plasma haemoglobin IVD, kit, enzyme immunohistochemistry

CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c RGT. KIT BL-300 by Carolina Liquid Chemistries Corp. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Free plasma haemoglobin IVD, kit, enzyme immunohistochemistry.

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 d35932b6-29cb-46cf-97bb-caded6d425f8 37 fields · synced May 30, 2026