SAS Legionella Controls

FDA UDI

by Sa Scientific, Ltd

Identity

Trade Name: SAS Legionella Controls FDA UDI
Generic Name: Legionella pneumophila antigen IVD, control FDA UDI
Device Name: SAS™ Legionella Controls are for use in monitoring the in vitro diagnostic performance of the SAS™ Legionella Test presumptive qualitative detection of Legionella pneumophila serogroup 1 antigens in human urine; their performance has not been evaluated with other Legionella assays. These controls are for prescription use only. FDA UDI
Model / Reference: 044413 FDA UDI
Description: SAS™ Legionella Controls are for use in monitoring the in vitro diagnostic performance of the SAS™ Legionella Test presumptive qualitative detection of Legionella pneumophila serogroup 1 antigens in human urine; their performance has not been evaluated with other Legionella assays. These controls are for prescription use only. FDA UDI

Identifiers

Primary DI / UDI-DI: 00780311000141 FDA UDI
GMDN Term: Legionella pneumophila antigen IVD, control FDA UDI

Classification

Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Legionella pneumophila antigen IVD, control

SAS Legionella Controls by Sa Scientific, Ltd — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Legionella pneumophila antigen IVD, control.

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BinaxNOW™ Legionella Control Swab Pack — Alere Scarborough, Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	N/A	Pending data

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Manufacturer

Manufacturer: Sa Scientific, Ltd

Sources (1)

FDA UDI de306e16-90b1-40c1-a8bc-2ca7f76d633d 33 fields · synced May 30, 2026