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UltraCrit Loaner

FDA UDI

Class II (US FDA UDI)

by Separation Technology, Inc.

Identity

Trade Name
UltraCrit Loaner FDA UDI
Generic Name
Haematocrit analyser IVD FDA UDI
Device Name
UltraCrit Hematocrit measurement device (UltraCrit) employs ultrasound technology to accurately measure hematocrit (Hct) in whole blood. For In-Vitro diagnostics use. FDA UDI
Model / Reference
100-201 FDA UDI
Description
UltraCrit Hematocrit measurement device (UltraCrit) employs ultrasound technology to accurately measure hematocrit (Hct) in whole blood. For In-Vitro diagnostics use. FDA UDI

Identifiers

Catalog Number
100-201 FDA UDI
Primary DI / UDI-DI
00831829000427 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

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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Haematocrit analyser IVD

UltraCrit Loaner 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 a3c00d47-eb97-4611-a714-01fcf429c078 36 fields · synced May 30, 2026