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UltraChek Reference Controls High

FDA UDI

Class II (US FDA UDI)

by Separation Technology, Inc.

Identity

Trade Name
UltraChek Reference Controls High FDA UDI
Generic Name
Haematocrit analyser IVD FDA UDI
Device Name
For use only with the UltraCrit™ hematocrit measurement device and UltraCrit quality control (QC) cuvettes. FDA UDI
Model / Reference
300-118 FDA UDI
Description
For use only with the UltraCrit™ hematocrit measurement device and UltraCrit quality control (QC) cuvettes. FDA UDI

Identifiers

Catalog Number
300-118 FDA UDI
Primary DI / UDI-DI
00831829000106 FDA UDI
FDA Product Code
GKF FDA UDI
GMDN Term
Haematocrit analyser IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.5600 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

No

FDA UDI

Category: Haematocrit analyser IVD

UltraChek Reference Controls High by Separation Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haematocrit analyser IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Separation Technology, Inc.

Sources (1)

  • FDA UDI d4f7c9c9-79f9-4fe6-a0dc-4034c83729e7 36 fields · synced May 31, 2026