HemosIL CL HIT-IgG(PF4-H)

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 23 Oct 2026.

Generic Name

Platelet factor 4 IVD, kit, enzyme immunoassay (EIA)

Model / Ref / Catalog

0029706200, 00029706200

Primary DI / UDI-DI

00195226001204

Basic UDI-DI

0195226001204PZ

Direct Marketing DI

00195226001204

510(k) Number

K243374 ↗

FDA Product Code

LCO

EMDN Code

W0103020402 Platelet factor 4

GMDN Term

Platelet factor 4 IVD, kit, enzyme immunoassay (EIA)

Device Class

Class B EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 864.7695

EU market of registration

Italy

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• HemosIL Silica Clotting Time

  Class II

  FDA 510(k) K253957 Active Cleared 9 Jan 2026

• GEM Premier 5000 PAK BG/COOX/TBILI 150 TEST 00055415005

  Class II

  GUDID on market

• GEM CVP (Calibration Validation Product) Level 4 00024001814

  Class I

  CE/IVDR IVDR 727804 Active Valid to Oct 2031 GUDID on market

• HemosIL RecombiPlasTin 2G (8 mL) 00020002950

  Class II

  CE/IVDR GUDID on market

• ChemSTAT Hematocrit Evaluator 1 00044000104

  Class II

  GUDID on market

• Coatest SP FVIII 82 4086 63

  Class II

  GUDID on market

See all devices from Instrumentation Laboratory Company →

• What is the HemosIL CL HIT-IgG (PF4-H) used to detect and how does it help in clinical settings?

  The HemosIL CL HIT-IgG (PF4-H) is a diagnostic test designed to detect and quantify IgG antibodies against platelet factor 4 (PF4) in human plasma. These antibodies are linked to heparin-induced thrombocytopenia (HIT), a serious condition that can cause dangerous blood clots. By providing a quantitative measurement, it helps clinicians confirm suspected HIT cases more accurately, enabling faster and more informed treatment decisions.

• Is the HemosIL CL HIT-IgG (PF4-H) intended for single-use or repeated use, and what preparation is required?

  The HemosIL CL HIT-IgG (PF4-H) is supplied as a single-use reagent kit and is not sterile. It requires reconstitution and preparation according to the manufacturer’s instructions before use, as outlined in the accompanying documentation.

• How should the HemosIL CL HIT-IgG (PF4-H) be stored, and are there any special handling requirements?

  Storage and handling of the HemosIL CL HIT-IgG (PF4-H) must follow standard laboratory protocols for immunoassay reagents. Since it is not sterile, it should be stored in a controlled environment to maintain its integrity until use, as specified in the manufacturer’s guidelines.

• What regulatory pathways has the HemosIL CL HIT-IgG (PF4-H) followed, and what does this mean for its use?

  The HemosIL CL HIT-IgG (PF4-H) has received FDA 510(k) clearance, demonstrating it is substantially equivalent to a predicate device, and it is classified under the EU’s In Vitro Diagnostic Regulation (IVDR). This means it meets regulatory standards for safety, performance, and clinical utility as an in vitro diagnostic device for detecting IgG antibodies in plasma.

• Where can I find more information about the regulatory submission details for the HemosIL CL HIT-IgG (PF4-H)?

  The regulatory submission for the HemosIL CL HIT-IgG (PF4-H) was filed under the product code LCO and reviewed by the FDA’s Hematology (HE) advisory committee. Additional details, including the clearance type (Traditional 510(k)), decision date (January 28, 2025), and other submission specifics, can be found in the FDA’s public database using the K-number K243374 or registration numbers listed.