HemosIL Apixaban Controls

FDA UDIEUDAMED

Class II (US FDA UDI)

by Instrumentation Laboratory Company

Identity

Trade Name: HemosIL Apixaban Controls FDA UDI
Generic Name: Coagulation factor Xa inhibitor IVD, control FDA UDI
Device Name: HemosIL Apixaban Controls kit consists of: 1. Apixaban Low Control (Cat. No. 0020015310): 5 x 1 mL vials 2. Apixaban High Control (Cat. No. 0020015320): 5 x 1 mL vials FDA UDI
Model / Reference: 0020015300 FDA UDI
Description: HemosIL Apixaban Controls kit consists of: 1. Apixaban Low Control (Cat. No. 0020015310): 5 x 1 mL vials 2. Apixaban High Control (Cat. No. 0020015320): 5 x 1 mL vials FDA UDI

Identifiers

Catalog Number: 00020015300 FDA UDI
Primary DI / UDI-DI: 00195226000030 FDA UDI
FDA Product Code: GGN FDA UDI
GMDN Term: Coagulation factor Xa inhibitor IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.5425 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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: Coagulation factor Xa inhibitor IVD, control

HemosIL Apixaban Controls by Instrumentation Laboratory Company — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Coagulation factor Xa inhibitor IVD, control.

INNOVANCE Apixaban Controls — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
INNOVANCE Apixaban Controls — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
HEMOSIL RIVAROXABAN CONTROLS — INSTRUMENTATION LABORATORY COMPANY · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	IVDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Instrumentation Laboratory Company

Sources (2)

FDA UDI 8c327363-5860-4d96-91ad-fba2a4c62c2e 36 fields · synced Jun 18, 2026
EUDAMED 1 fields · synced Jun 3, 2026