Product Code: LSE
FDA class 1
21 CFR 866.3235
Epstein-Barr Virus, Other
Microbiology
Epstein-Barr virus (EBV) diagnostic reagents (other types) are in vitro diagnostic products that use various methodologies beyond the standard EBV-specific antibody tests to detect EBV infection or associated conditions in clinical specimens. They are classified as a Class 1 (lowest risk) device, subject only to general controls, representing the least burdensome regulatory category. The product code is LSE, regulated under 21 CFR 866.3235, within the Microbiology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
510(k)s
56
FEI Numbers
16
Registration Numbers
16
Unique Applicants
26
Years Active
37
Basic Information
- Product Code
- LSE
- Device Class
- FDA class 1
- Regulation Number
- 866.3235
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 56 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K233606 | ADVIA Centaur EBV-VCA IgM | Aug 07, 2024 | Substantially Equivalent | Biokit S.A. |
| K162961 | LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set | Jan 05, 2017 | Substantially Equivalent | DIASORIN INC. |
| K162959 | LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set | Jan 04, 2017 | Substantially Equivalent | DIASORIN INC. |
| K091260 | SERAQUEST EBV EA-D IGG TEST | Jun 08, 2009 | Substantially Equivalent | QUEST INTL., INC. |
| K073382 | PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G | Jul 28, 2008 | Substantially Equivalent | FOCUS DIAGNOSTICS, INC. |
| K062213 | BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | Dec 08, 2006 | Substantially Equivalent | BIO-RAD LABORATORIES, INC. |
| K062211 | BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | Dec 08, 2006 | Substantially Equivalent | BIO-RAD LABORATORIES, INC. |
| K060204 | LIAISON EA IGG | Oct 18, 2006 | Substantially Equivalent | DIASORIN, INC. |
| K033915 | MODIFICATION TO SERAQUEST EB VCA IGG | Jan 16, 2004 | Substantially Equivalent | QUEST INTL., INC. |
| K030863 | EBV VCA-P18 IGG ELISA | Jun 27, 2003 | Substantially Equivalent | PANBIO LIMITED |
| K021793 | EBV EA-D IGG ELISA KIT, MODEL EBG-100 | Sep 27, 2002 | Substantially Equivalent | PAN BIO PTY. LTD. |
| K010301 | IMMUNOWELL EA (D) IGG TEST | Jun 11, 2001 | Substantially Equivalent | GenBio |
| K992587 | EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM | Dec 22, 1999 | Substantially Equivalent | STELLAR BIO SYSTEMS, INC. |
| K991975 | SERAQUEST EB NA IGG | Nov 02, 1999 | Substantially Equivalent | QUEST INTL., INC. |
| K990410 | SERAQUEST EB VCA IGG | Oct 28, 1999 | Substantially Equivalent | QUEST INTL., INC. |
| K992191 | ETI-EA-G ASSAY | Jul 12, 1999 | Substantially Equivalent | DIASORIN, INC. |
| K983842 | BIOTEST ANTI-EBV RECOMBINANT, EA IGM | Jun 09, 1999 | Substantially Equivalent | BIOTEST DIAGNOSTICS CORP. |
| K983841 | BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG | Jun 09, 1999 | Substantially Equivalent | BIOTEST DIAGNOSTICS CORP. |
| K983839 | BIOTEST ANTI-EBV RECOMBINANT | Jun 09, 1999 | Substantially Equivalent | BIOTEST DIAGNOSTICS CORP. |
| K991660 | COPALIS MULTIPLEX EBV ANTIBODY ASSAY | Jun 04, 1999 | Substantially Equivalent | DIASORIN, INC. |
| K981812 | EBV-VCA IGG ELISA TEST SYSTEM | Mar 04, 1999 | Substantially Equivalent | DIAMEDIX CORP. |
| K983801 | THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO | Dec 10, 1998 | Substantially Equivalent | ZEUS SCIENTIFIC, INC. |
| K983804 | THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR | Dec 08, 1998 | Substantially Equivalent | ZEUS SCIENTIFIC, INC. |
| K982352 | VCA IGM ELISA TEST SYSTEM | Nov 25, 1998 | Substantially Equivalent | COLUMBIA BIOSCIENCE, INC. |
| K982350 | EA-D IGM ELISA TEST SYSTEM | Nov 25, 1998 | Substantially Equivalent | COLUMBIA BIOSCIENCE, INC. |
| K982348 | EBNA-1 IGM ELISA TEST SYSTEM | Nov 25, 1998 | Substantially Equivalent | COLUMBIA BIOSCIENCE, INC. |
| K974244 | IMMUNODOT MONO-M TEST | Sep 22, 1998 | Substantially Equivalent | GenBio |
| K974226 | IMMUNODOT MONO-G TEST | Sep 22, 1998 | Substantially Equivalent | GenBio |
| K981120 | ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA | Aug 21, 1998 | Substantially Equivalent | ZEUS SCIENTIFIC, INC. |
| K973940 | IMMUNOWELL EBV VCA IGG TEST | Aug 10, 1998 | Substantially Equivalent | GenBio |
| K980912 | VCA IGG ELISA TEST SYSTEM | Jul 22, 1998 | Substantially Equivalent | CLARK LABORATORIES, INC. |
| K980596 | VCA IGM ELISA TEST SYSTEM | Jul 22, 1998 | Substantially Equivalent | CLARK LABORATORIES, INC. |
| K973123 | EA-D IGG ELISA TEST SYSTEM | Mar 26, 1998 | Substantially Equivalent | CLARK LABORATORIES, INC. |
| K944449 | EBV-VCA IGM ELISA TEST STSTEM | Sep 25, 1995 | Substantially Equivalent | ZEUS SCIENTIFIC, INC. |
| K940093 | EBV-EA(D) IGG ELISA TEST | Sep 15, 1995 | Substantially Equivalent | GULL LABORATORIES, INC. |
| K941198 | EBV LGG ELISA TEST | Aug 23, 1995 | Substantially Equivalent | GULL LABORATORIES, INC. |
| K946159 | INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KIT | Jun 07, 1995 | Substantially Equivalent | INCSTAR CORP. |
| K946157 | INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KIT | Jun 07, 1995 | Substantially Equivalent | INCSTAR CORP. |
| K934774 | UNKNOWN | Apr 20, 1994 | Substantially Equivalent | GRANBIO, INC. |
| K931443 | ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS | Nov 05, 1993 | Substantially Equivalent | ORTHO DIAGNOSTIC SYSTEMS, INC. |
| K925688 | MERIDIAN EBV-EA TEST KIT | Oct 12, 1993 | Substantially Equivalent | FULLER LABORATORIES, INC. |
| K921628 | EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA | Sep 14, 1992 | Substantially Equivalent | INCSTAR CORP. |
| K922332 | BARTELS EPSTEIN-BARR VIRUS IGG EIA | Sep 02, 1992 | Substantially Equivalent | BAXTER DIAGNOSTICS, INC. |
| K912489 | COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS | Jul 24, 1991 | Substantially Equivalent | IMMUNO CONCEPTS, INC. |
| K912488 | FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS | Jul 24, 1991 | Substantially Equivalent | IMMUNO CONCEPTS, INC. |
| K903612 | EBV/EA-CHECK TM TEST KIT | Oct 16, 1990 | Substantially Equivalent | DIAGNOSTIC TECHNOLOGY, INC. |
| K895652 | EBV-EA IFA KIT | Dec 18, 1989 | Substantially Equivalent | ORGANON TEKNIKA TREYBURN |
| K894932 | FIAX EB VCA-M TEST KIT | Oct 16, 1989 | Substantially Equivalent | WHITTAKER BIOPRODUCTS, INC. |
| K894235 | EB VCA STAT M TEST KIT | Aug 30, 1989 | Substantially Equivalent | WHITTAKER BIOPRODUCTS, INC. |
| K883871 | EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590 | Jul 14, 1989 | Substantially Equivalent | CLINICAL SCIENCES, INC. |
| K883870 | EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590 | Jul 14, 1989 | Substantially Equivalent | CLINICAL SCIENCES, INC. |
| K891086 | STAT TEST KIT FOR EB-VCA IGG ANTIBODY | May 10, 1989 | Substantially Equivalent | WHITTAKER BIOPRODUCTS, INC. |
| K882447 | EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) ANTIBODY TES | Dec 15, 1988 | Substantially Equivalent | ZEUS SCIENTIFIC, INC. |
| K882023 | FIAX TEST KIT FOR EB-VCA-G ANTIBODY | Aug 03, 1988 | Substantially Equivalent | WHITTAKER BIOPRODUCTS, INC. |
| K881617 | INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY | Jun 07, 1988 | Substantially Equivalent | GRANBIO, INC. |
| K872617 | EBV-EA TEST | Jan 05, 1988 | Substantially Equivalent | GULL LABORATORIES, INC. |
FEI Numbers
This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.