Dade® Sickle-Trol Hemoglobin Controls

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name: Dade® Sickle-Trol Hemoglobin Controls FDA UDI
Generic Name: Haemoglobin S (HbS) IVD, control FDA UDI
Device Name: For testing for the presence of hemoglobin S in solubility tests and hemoglobing electrophoresis FDA UDI
Model / Reference: 10459401 FDA UDI
Description: For testing for the presence of hemoglobin S in solubility tests and hemoglobing electrophoresis FDA UDI

Identifiers

Catalog Number: B4585-10 FDA UDI
Primary DI / UDI-DI: 00630414976358 FDA UDI
FDA Product Code: GGM FDA UDI
GMDN Term: Haemoglobin S (HbS) IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.8625 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: Haemoglobin S (HbS) IVD, control

Dade® Sickle-Trol Hemoglobin Controls by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Siemens Healthcare Diagnostics Products Ltd

Sources (1)

FDA UDI 088d5885-8980-4686-861e-28ef800e656a 36 fields · synced May 31, 2026