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Difftrol

FDA UDI

Class II (US FDA UDI)

by Horiba Instruments Incorporated

Identity

Trade Name
DIFFTROL FDA UDI
Generic Name
Full blood count IVD, control FDA UDI
Device Name
Whole Blood Hematology Control FDA UDI
Model / Reference
3x3 mL FDA UDI
Description
Whole Blood Hematology Control FDA UDI

Identifiers

Catalog Number
5300100112 FDA UDI
Primary DI / UDI-DI
00856605006066 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

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

Yes

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: Full blood count IVD, control

Difftrol by Horiba Instruments Incorporated — 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
Horiba Instruments Incorporated

Sources (1)

  • FDA UDI 431b11fa-aeb4-4d4d-9076-09b257eae5c7 35 fields · synced Jun 6, 2026