Chrysalis Intelligence · Sponsors · Abbott Diagnostics Scarborough, Inc.

Abbott Diagnostics Scarborough, Inc.

Scarborough, ME, US · 6 510(k) clearances · 2 PMAs · 7 recalls

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Total clearances

2022-06-24 → 2026-08-31

Last 12 months

Product codes

Most recent

2026-08-31

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Class II	Microbiology	2	2026-08-31
QVF	Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings	Class II	Microbiology	1	2025-06-13
QYT	Over-The-Counter Covid-19 Antigen Test	Class II	Microbiology	1	2025-02-11
QWR	Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings	Class II	Microbiology	1	2023-08-10
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay	Class II	Microbiology	1	2022-06-24

Class III

PMA approvals (2)

Total PMA records

Originals + supplements

Distinct product codes

First decision

2021-06-15

Most recent

2022-07-12

Date	PMA #	Trade name	Type	Code	Device name	Specialty
2022-07-12	P940035-S017	NMP22 BladderChek Test	Normal 180 Day Track No User Fee	NAH	System, Test, Tumor Marker, For Detection Of Bladder Cancer	Unknown
2021-06-15	P940035-S016	Alere NMP22 BladderChek Test	30-Day Notice	NAH	System, Test, Tumor Marker, For Detection Of Bladder Cancer	Unknown

Safety

Recalls (7)

Class I (serious)

Risk of injury / death

Total recalls

Currently ongoing

Most recent

2026-02-09

Date	Severity	Status	Recall #	Product	Code	Reason
2026-02-09	Class II	Ongoing	Z-1565-2026	Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Descri…	—	It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
2025-03-04	Class II	Ongoing	Z-1576-2025	Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Desc…	—	the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
2025-03-04	Class II	Ongoing	Z-1575-2025	Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software V…	—	the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
2025-03-04	Class II	Ongoing	Z-1574-2025	Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version…	—	the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
2025-03-04	Class II	Ongoing	Z-1573-2025	Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Desc…	—	The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
2025-03-04	Class II	Ongoing	Z-1572-2025	Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software V…	—	The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
2025-03-04	Class II	Ongoing	Z-1571-2025	Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version…	—	The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

Filings

All 510(k) clearances (6)

Date	K-number	Device	Code	Class	Specialty
2026-08-31	K262747	ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0	OCC	Class II	Microbiology
2025-06-13	K250273	BinaxNOW COVID-19 Ag Card	QVF	Class II	Microbiology
2025-02-11	K243518	BinaxNOW COVID-19 Antigen Self Test	QYT	Class II	Microbiology
2023-10-10	K232775	ID NOW Influenza A & B 2	OCC	Class II	Microbiology
2023-08-10	K221925	ID NOW COVID-19 2.0	QWR	Class II	Microbiology
2022-06-24	K220801	ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2	OZE	Class II	Microbiology