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Rals

FDA UDI

Class I (US FDA UDI)

by Abbott Rapid Diagnostics Informatics, Inc.

Identity

Trade Name
RALS FDA UDI
Generic Name
Medical equipment clinical data interfacing software FDA UDI
Device Name
RALS test results capturing and data transferring software FDA UDI
Model / Reference
8.1.1 FDA UDI
Description
RALS test results capturing and data transferring software FDA UDI

Identifiers

Catalog Number
8.1.1 FDA UDI
Primary DI / UDI-DI
00850049633130 FDA UDI
FDA Product Code
JQP FDA UDI
GMDN Term
Medical equipment clinical data interfacing software FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2100 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Medical equipment clinical data interfacing software

Rals by Abbott Rapid Diagnostics Informatics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical equipment clinical data interfacing software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Rapid Diagnostics Informatics, Inc.

Sources (1)

  • FDA UDI b3a73ffe-778c-48a6-bf86-e2a44659c654 35 fields · synced May 31, 2026