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HemosIL Liquid Anti-Xa

FDA UDI

Class II (US FDA UDI)

by Instrumentation Laboratory Company

Identity

Trade Name
HemosIL Liquid Anti-Xa FDA UDI
Generic Name
Coagulation factor Xa inhibitor IVD, kit, clotting FDA UDI
Device Name
HemosIL Liquid Anti-Xa 1. Factor Xa Reagent (0020303610) 5 x 5mL 2. Chromogenic substrate (0020303620) 5 x 6mL FDA UDI
Model / Reference
0020303600 FDA UDI
Description
HemosIL Liquid Anti-Xa 1. Factor Xa Reagent (0020303610) 5 x 5mL 2. Chromogenic substrate (0020303620) 5 x 6mL FDA UDI

Identifiers

Catalog Number
00020303600 FDA UDI
Primary DI / UDI-DI
00195226000054 FDA UDI
510(k) Number
DEN190032 FDA UDI
K213464 FDA UDI
FDA Product Code
QLU FDA UDI
GMDN Term
Coagulation factor Xa inhibitor IVD, kit, clotting FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7295 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Coagulation factor Xa inhibitor IVD, kit, clotting

HemosIL Liquid Anti-Xa by Instrumentation Laboratory Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coagulation factor Xa inhibitor IVD, kit, clotting.

Cleared under the same submission

DEN190032 also covers:

K213464 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Instrumentation Laboratory Company

Sources (1)

  • FDA UDI 04a8b52c-235b-438e-9574-8d76ef375c1a 37 fields · synced May 30, 2026