Data / Medical devices / United States / Orasure Technologies Inc.
Orasure Technologies Inc.: FDA-registered device maker in Bethlehem, PA, United States, 1 510(k) clearance and 1 PMA approval
Orasure Technologies Inc. is registered with the FDA (registration 3004142665) in Bethlehem, PA, United States. It lists 8 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated October 10, 2019. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004142665
- Address
- 220 East First Street, Bethlehem, PA, United States, 18015
- Owner or operator
- ORASURE TECHNOLOGIES, INC. (9000083)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 19, 2007
- Registered through
- 2027
- Brand names listed
- Colli-Pee Dx Urine Collection Kit, InteliSwab COVID-19 Rapid Test, InteliSwab COVID-19 Rapid Test Pro, InteliSwab COVID-19 Rapid Test Rx, OMNIgene-GUT (OMD-200), ORAcollect DNA (OCR-100), ORAcollect DNA (ORE-100), ORAcollect Dx (OCD-100, OCD-100A) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus | MZO | 2 | Manufacturer | accessdata.fda.gov |
| Coronavirus Antigen Detection Test System. | QKP | N | Manufacturer | accessdata.fda.gov |
| Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay | SIH | 2 | Contract manufacturer | accessdata.fda.gov |
| Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens | QID | 2 | Manufacturer | accessdata.fda.gov |
| Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples | QPO | 2 | Contract manufacturer | accessdata.fda.gov |
| Dna Specimen Collection, Saliva | OYJ | 2 | Contract manufacturer | accessdata.fda.gov |
| Hiv Self-Tests | QSS | 3 | Manufacturer | accessdata.fda.gov |
| Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test | QSU | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 10, 2019 | DEN190025 | OraQuick Ebola Rapid Antigen Test | QID | Unknown | OraSure Technologies, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| June 25, 2010 | P080027 | ORAQUICK HCV RAPID ANTIBODY TEST | MZO | 35 | April 20, 2021 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 5, 2021 | 87340 | Class III | Terminated | 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) lot 6676239, but contained Substrate Reagent (TMB) lot 6679623, should not affect performance. | accessdata.fda.gov |
| July 15, 2020 | 86312 | Class III | Terminated | CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of common warts and plantar warts. | Unit boxes not properly sealed | accessdata.fda.gov |
| July 13, 2020 | 86122 | Class III | Terminated | Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB | Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box | accessdata.fda.gov |
Compare with other makers
- All makers of Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- All makers of Hiv Self-Tests
- All makers of Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test
- All makers of Dna Specimen Collection, Saliva
Updated April 20, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.