Sickledex

FDA UDI

Class II (US FDA UDI)

by Streck

Identity

Trade Name: SICKLEDEX FDA UDI
Generic Name: Haemoglobin S (HbS) IVD, control FDA UDI
Device Name: A qualitative solubility test kit used to detect the presence of sickling hemoglobins in human blood or sickle cell control material. Contains 100 tests. FDA UDI
Model / Reference: 217657 FDA UDI
Description: A qualitative solubility test kit used to detect the presence of sickling hemoglobins in human blood or sickle cell control material. Contains 100 tests. FDA UDI

Identifiers

Catalog Number: 217657 FDA UDI
Primary DI / UDI-DI: 00844509002048 FDA UDI
510(k) Number: K023656 FDA UDI
FDA Product Code: GHM FDA UDI
GMDN Term: Haemoglobin S (HbS) IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.7825 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

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: Haemoglobin S (HbS) IVD, control

Sickledex by Streck — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemoglobin S (HbS) IVD, control.

Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC. · Class II
Thermo Scientific Pacific Hemostasis® — Fisher Diagnostics · Class II
Sickle-Heme — GREAT LAKES DIAGNOSTICS, INC. · Class II
Dade® Sickle-Trol Hemoglobin Controls — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC. · Class II
SICKLEDEX — Streck · Class II
Sickle-Chex — Streck · Class II
Sickle-Chex — Streck · Class II

Cleared under the same submission

K023656 also covers:

SICKLEDEX — Streck
SICKLEDEX — Streck

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: Streck

Sources (1)

FDA UDI 8b5f3956-2b9e-492c-8ad2-59684b109768 37 fields · synced May 30, 2026