Hemoglobin Total Normal Control

FDA UDI

Class II (US FDA UDI)

by Analytical Control Systems

Identity

Trade Name: Hemoglobin Total Normal Control FDA UDI
Generic Name: Inherited haemoglobinopathy IVD, control FDA UDI
Model / Reference: HC-110 FDA UDI

Identifiers

Catalog Number: HC-110 FDA UDI
Primary DI / UDI-DI: 00817869020168 FDA UDI
510(k) Number: K802568 FDA UDI
FDA Product Code: KHG FDA UDI
GMDN Term: Inherited haemoglobinopathy IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.7500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Inherited haemoglobinopathy IVD, control

Hemoglobin Total Normal Control by Analytical Control Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Inherited haemoglobinopathy IVD, control.

ASA2 Hemo Control — Helena Laboratories, Corp. · Class II
AA2 Hemo Control — Helena Laboratories, Corp. · Class II
AFSC Hemo Control — Helena Laboratories, Corp. · Class II
Hemoglobin Variants System — Bio-Rad Laboratories · Class II
VARIANT nbs — Bio-Rad Laboratories · Class II
AFSA2 Hemo Control — Helena Laboratories, Corp. · Class II
Hemoglobin Variants System — Bio-Rad Laboratories · Class II
Hemoglobin A2 Elevated Control — Analytical Control Systems · Class II

Cleared under the same submission

K802568 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Analytical Control Systems

Sources (1)

FDA UDI 3ff644e0-1ecd-44e8-aba8-d200c8fc261b 34 fields · synced May 30, 2026