HbA1c CONTROL L+ H

FDA UDIEUDAMED

by Vitalscientific

Identity

Trade Name: HbA1c CONTROL L+ H FDA UDI
Generic Name: Glycated haemoglobin (HbA1c) IVD, control FDA UDI
Model / Reference: HBAC-0049 FDA UDI

Identifiers

Primary DI / UDI-DI: 03701700828907 FDA UDI
GMDN Term: Glycated haemoglobin (HbA1c) IVD, control FDA UDI

Classification

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

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

Category: Glycated haemoglobin (HbA1c) IVD, control

HbA1c CONTROL L+ H by Vitalscientific — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Glycated haemoglobin (HbA1c) IVD, control.

Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
HbA1C CONTROL — Randox Laboratories, Ltd. · Class I
Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
HbA1c — POINTE SCIENTIFIC, INC. · Class II
MAS Diabetes Max, Multi-pack — Microgenics Corporation · Class I
MULTI-SYSTEM Hb A1c CAPILLARY CONTROLS (2) — Sebia, Inc. · Class I
PreciControl HbA1c path — Roche Diagnostics Corp. · Class I
Liquichek — Bio-Rad Laboratories · Class I

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	IVDR	—	N/A	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	N/A	Pending data

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Manufacturer

Manufacturer: Vitalscientific

Sources (2)

FDA UDI 859583fb-8af1-4a14-8721-a3205528d97a 32 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 3, 2026