Ricca Chemical Company®

FDA UDI

Class I (US FDA UDI)

by Ricca Chemical Company Llc

Identity

Trade Name: Ricca Chemical Company® FDA UDI
Generic Name: Red blood cell count IVD, reagent FDA UDI
Device Name: Hayem Diluting Fluid, for Erythrocyte (Red Cell) Count FDA UDI
Model / Reference: 3500-16 FDA UDI
Description: Hayem Diluting Fluid, for Erythrocyte (Red Cell) Count FDA UDI

Identifiers

Catalog Number: 3500 FDA UDI
Primary DI / UDI-DI: 00192024036186 FDA UDI
FDA Product Code: GJN FDA UDI
GMDN Term: Red blood cell count IVD, reagent FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.8200 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Red blood cell count IVD, reagent

Ricca Chemical Company® by Ricca Chemical Company Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Red blood cell count IVD, reagent.

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EryCount pur — BIOANALYTIC GmbH, biomed. Analysentechnik · Class I
Erythrocyte Fragility (osmotic) — BIOANALYTIC GmbH, biomed. Analysentechnik · Class I
Ery-TIC 1:200 plus — BIOANALYTIC GmbH, biomed. Analysentechnik · Class I
EryCount pur — BIOANALYTIC GmbH, biomed. Analysentechnik · Class I
Ery-TIC 1:200 — BIOANALYTIC GmbH, biomed. Analysentechnik · Class I
Ricca Chemical Company® — RICCA CHEMICAL COMPANY LLC · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Ricca Chemical Company Llc

Sources (1)

FDA UDI 2c8a1101-4814-4c9d-a5b4-505a6ec7305e 35 fields · synced Sep 18, 2026