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CellaVision® Body Fluid Application DM96

FDA UDI

Class II (US FDA UDI)

by Cellavision AB

Identity

Trade Name
CellaVision® Body Fluid Application DM96 FDA UDI
Generic Name
Laboratory instrument/analyser application software IVD FDA UDI
Device Name
The body fluid application automatically locates and presents cell images on cytocentrifuged body fluid preparations. FDA UDI
Model / Reference
CBF-960099 FDA UDI
Description
The body fluid application automatically locates and presents cell images on cytocentrifuged body fluid preparations. FDA UDI

Identifiers

Catalog Number
CBF-960099 FDA UDI
Primary DI / UDI-DI
07350040972564 FDA UDI
510(k) Number
K080595 FDA UDI
FDA Product Code
GKZ FDA UDI
JOY FDA UDI
GMDN Term
Laboratory instrument/analyser application software IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.5220 FDA UDI
864.5260 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Laboratory instrument/analyser application software IVD

CellaVision® Body Fluid Application DM96 by Cellavision AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laboratory instrument/analyser application software IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cellavision AB

Sources (1)

  • FDA UDI a84e7927-1120-419b-85ea-b718f146f398 36 fields · synced May 30, 2026