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Coulter Lin-X

FDA UDI

Class II (US FDA UDI)

by Beckman Coulter, Inc.

Identity

Trade Name
COULTER LIN-X FDA UDI
Generic Name
Full blood count IVD, control FDA UDI
Device Name
COULTER LIN-X Linearity Control FDA UDI
Model / Reference
A81196 FDA UDI
Description
COULTER LIN-X Linearity Control FDA UDI

Identifiers

Catalog Number
A81196 FDA UDI
Primary DI / UDI-DI
15099590206802 FDA UDI
FDA Product Code
JPK FDA UDI
GMDN Term
Full blood count IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.8625 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

Yes

FDA UDI

Category: Full blood count IVD, control

Coulter Lin-X by Beckman Coulter, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Full blood count IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Beckman Coulter, Inc.

Sources (1)

  • FDA UDI 3ea89e22-4a7d-4536-a7b7-7d83d9c962d4 35 fields · synced Jun 8, 2026