Chrysalis Intelligence · Sponsors · OraSure Technologies, Inc.

OraSure Technologies, Inc.

0 510(k) clearances · 3 PMAs · 6 recalls

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals

Total clearances

0

None → None

Last 12 months

0

Product codes

0

Most recent

—

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent

Class III

PMA approvals (3)

Total PMA records

3

Originals + supplements

Distinct product codes

1

First decision

2020-10-16

Most recent

2021-04-20

Date	PMA #	Trade name	Type	Code	Device name	Specialty
2021-04-20	P080027-S039	OraQuick HCV Rapid Antibody Test	30-Day Notice	MZO	Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	Microbiology
2021-02-25	P080027-S038	OraQuick HCV Rapid Antibody Test	30-Day Notice	MZO	Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	Microbiology
2020-10-16	P080027-S037	OraQuick HCV Rapid Antibody Test	30-Day Notice	MZO	Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	Microbiology

Safety

Recalls (6)

Class I (serious)

0

Risk of injury / death

Total recalls

6

Currently ongoing

0

Most recent

2021-02-05

Date	Severity	Status	Recall #	Product	Code	Reason
2021-02-05	Class III	Terminated	Z-1183-2021	Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C…	—	Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the specification sheet listed the Substrate Reagent (TMB…
2020-07-15	Class III	Terminated	Z-3003-2020	Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 1001-0280 - Product Usage: indicated for over-…	—	Unit boxes not properly sealed
2020-07-15	Class III	Terminated	Z-3002-2020	Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage: indicated for over-the-counter a cr…	—	Unit boxes not properly sealed
2020-07-15	Class III	Terminated	Z-3001-2020	CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for over-the-counter a cryosurgical …	—	Unit boxes not properly sealed
2020-07-13	Class III	Terminated	Z-2877-2020	Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD …	—	Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
2020-07-13	Class III	Terminated	Z-2876-2020	Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Im…	—	Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box

Filings

510(k) clearances (none indexed)

Date	K-number	Device	Code	Class	Specialty