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Id Now Rsv

FDA UDI

Class II (US FDA UDI)

by Alere Scarborough, Inc.

Identity

Trade Name
ID NOW RSV FDA UDI
Generic Name
Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
A rapid, automated, molecular test for the qualitative detection of respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal specimens. FDA UDI
Model / Reference
435-000 FDA UDI
Description
A rapid, automated, molecular test for the qualitative detection of respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal specimens. FDA UDI

Identifiers

Primary DI / UDI-DI
10811877010521 FDA UDI
510(k) Number
K161375 FDA UDI
FDA Product Code
OCC FDA UDI
OEM FDA UDI
OOI FDA UDI
GMDN Term
Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3980 FDA UDI
862.2570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Id Now Rsv by Alere Scarborough, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT).

Cleared under the same submission

K161375 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alere Scarborough, Inc.

Sources (1)

  • FDA UDI d3243c46-69da-4d31-8f09-3b282512421f 34 fields · synced May 30, 2026