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QuickScan 2000 (Windows 2000) Software and Computer, Version 2.01

FDA UDI

Class I (US FDA UDI)

by Helena Laboratories, Corp.

Identity

Trade Name
QuickScan 2000 (Windows 2000) Software and Computer, Version 2.01 FDA UDI
Generic Name
Densitometry analyser IVD FDA UDI
Model / Reference
1679000 FDA UDI

Identifiers

Primary DI / UDI-DI
M52516790000 FDA UDI
FDA Product Code
JQJ FDA UDI
GMDN Term
Densitometry analyser IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1630 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

No

FDA UDI

Category: Densitometry analyser IVD

QuickScan 2000 (Windows 2000) Software and Computer, Version 2.01 by Helena Laboratories, Corp. — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Densitometry analyser IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Helena Laboratories, Corp.

Sources (1)

  • FDA UDI 2df0deb5-4387-4545-8180-ea2958aa6053 33 fields · synced Jun 9, 2026