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HemosIL AcuStar Anti-B2GPI Domain 1 Controls

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 00009800022

by Instrumentation Laboratory Company

Identity

Trade Name
HemosIL AcuStar Anti-ß2GPI Domain 1 Controls EUDAMED
HemosIL AcuStar Anti-B2GPI Domain 1 Controls FDA UDI
Generic Name
Beta-2-glycoprotein I antibody IVD, control FDA UDI
Device Name
HemosIL AcuStar Anti-ß2GPI Domain 1 Controls EUDAMED
1. HemosIL Acustar ß2GP1-Domain1 Low Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives. 2. HemosIL Acustar ß2GP1-Domain1 High Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives. FDA UDI
Model / Reference
00009800022 EUDAMEDFDA UDI
Description
1. HemosIL Acustar ß2GP1-Domain1 Low Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives. 2. HemosIL Acustar ß2GP1-Domain1 High Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives. FDA UDI

Identifiers

Catalog Number
00009800022 FDA UDI
Primary DI / UDI-DI
08426951301706 EUDAMEDFDA UDI
Basic UDI-DI
842695130170668 EUDAMED
Direct Marketing DI
08426951301706 EUDAMED
510(k) Number
K152875 FDA UDI
FDA Product Code
JJX FDA UDI
EMDN Code
W0102100503 ANTI-B2-GLYCOPROTEIN I ANTIBODIES EUDAMED
GMDN Term
Beta-2-glycoprotein I antibody IVD, control FDA UDI

Classification

Device Class
Class B EUDAMED
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

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: Beta-2-glycoprotein I antibody IVD, control

HemosIL AcuStar Anti-B2GPI Domain 1 Controls by Instrumentation Laboratory Company — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED

Cleared under the same submission

K152875 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Instrumentation Laboratory Company

Sources (2)

  • FDA UDI 6aec0b80-174d-4adc-a0f8-c47e9d0c1579 37 fields · synced Jul 23, 2026
  • EUDAMED 98e75fd1-7a34-4fc7-b92b-b6cb4324cc5b 61 fields · synced Jul 23, 2026