Sickledex 217661

• FDA 510(k) K023656 decided 30 Dec 2002 Active
• FDA GUDID UDI-DI 00844509002024 listed 19 Sep 2016 Listed

1. 30 Dec 2002 Cleared FDA 510(k) K023656
2. 19 Sep 2016 Listed FDA GUDID 00844509002024

Trade name

Sickledex

Generic name

Haemoglobin S (HbS) IVD, control

Model / Ref / Catalog

217661

Description

A qualitative solubility test kit used to detect the presence of sickling hemoglobins in human blood or sickle cell control material. Contains 12 tests.

Primary DI / UDI-DI

00844509002024

510(k) Number

K023656 ↗

FDA product code

GHM

GMDN term

Haemoglobin S (HbS) IVD, control

Device class

Class II

Regulation number

864.7825

GUDID distribution status

In Commercial Distribution

Category: Haemoglobin S (HbS) IVD, control

Other devices filed under FDA product code GHM (Test, Sickle Cell).

• THROMBO SCREEN SICKLE CELL ASSAY SET by Pacific Hemostasis
• SICKLE HB ASSAY by Isolab, Inc.
• MONOJECT SICKLE CELL KIT by Sherwood Medical Co.
• SICKLE-HEME A/S HETEROZYGOUS CONTROL by MICHCLONE ASSOCIATES, INC.
• SICKLING HEMOGLOBIN CONTROLS, NORMAL by Isolab, Inc.
• THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT by Pacific Hemostasis
• SAS SICKLE CELL TEST by SA SCIENTIFIC, LTD
• SICKLE-HEME A/S CONTROLS & A/A CONTROL by Anco Medical Reagents & Assoc.
• SICKLE-CHEX by Streck Laboratories, Inc.
• SICKLE CELL REAGENT SET by MICHCLONE ASSOCIATES, INC.

• Cell-Free DNA BCT CE

  Class A

  CE/IVDR

• Xn Check Bf

  Class II

  FDA 510(k) K141957 Active Cleared 5 Dec 2014

• Cell-Free DNA BCT

  Class II

  FDA 510(k) K231776 Active Cleared 26 Jul 2024

• Xn Check

  Class II

  FDA 510(k) K160590 Active Cleared 22 Dec 2016

See all devices from Streck →