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UltraCrit Cuvettes

FDA UDI

Class II (US FDA UDI)

by Separation Technology, Inc.

Identity

Trade Name
UltraCrit Cuvettes FDA UDI
Generic Name
Laboratory analyser cuvette IVD, single-use FDA UDI
Device Name
UltraCrit Hematocrit Measurement Device (UltraCrit) employs ultrasound technology to accurately measure hematocrit (Hct) in whole blood. FDA UDI
Model / Reference
270-111 FDA UDI
Description
UltraCrit Hematocrit Measurement Device (UltraCrit) employs ultrasound technology to accurately measure hematocrit (Hct) in whole blood. FDA UDI

Identifiers

Catalog Number
270-111 FDA UDI
Primary DI / UDI-DI
00831829000021 FDA UDI
FDA Product Code
GKF FDA UDI
GMDN Term
Laboratory analyser cuvette IVD, single-use 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: Laboratory analyser cuvette IVD, single-use

UltraCrit Cuvettes by Separation Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laboratory analyser cuvette IVD, single-use.

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 5e3cec12-9665-4d90-bd2c-6f2eecc58b86 36 fields · synced May 30, 2026