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SecurView DX Manager

FDA UDI

Class I (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name
SecurView DX Manager FDA UDI
Generic Name
Laboratory instrument/analyser application software IVD FDA UDI
Device Name
The SecurView® DX diagnostic workstation Manager provides central database access and performs the image preparation for all connected SecurView DX Client workstations. FDA UDI
Model / Reference
SVDX Manager FDA UDI
Description
The SecurView® DX diagnostic workstation Manager provides central database access and performs the image preparation for all connected SecurView DX Client workstations. FDA UDI

Identifiers

Catalog Number
SVDX-00600-HIRES FDA UDI
Primary DI / UDI-DI
15420045507388 FDA UDI
FDA Product Code
LMD FDA UDI
GMDN Term
Laboratory instrument/analyser application software IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.2020 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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Laboratory instrument/analyser application software IVD

SecurView DX Manager by Hologic, Inc. — Class I — 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
Hologic, Inc.

Sources (1)

  • FDA UDI 3c23c34a-1c88-4581-8614-084f6a3e64b4 35 fields · synced Jun 6, 2026