LGC — Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific Class II
FDA product code LGC covers "Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific", a Class II medical device regulated under 21 CFR 866.3305. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LGC
- Device Class
- Class II
- Regulation Number
- 866.3305
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K033059 | trinity biotech | HERPES GROUP IGG | November 26, 2003 |
| K010878 | diagnostic products | MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6 | April 18, 2001 |
| K002262 | diamedix | DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM | November 28, 2000 |
| K000238 | mrl diagnostics | HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G | April 14, 2000 |
| K992166 | zeus scientific | THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYM | September 3, 1999 |
| K983886 | diagnology | POCKIT HSV 2 RAPID TEST | August 19, 1999 |
| K984346 | meridian diagnostics | PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST | June 25, 1999 |
| K983656 | zeus scientific | HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM | March 18, 1999 |
| K983541 | gull laboratories | HSV 1+2 IGG ELISA TEST | February 26, 1999 |
| K981306 | diamedix | DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM | September 29, 1998 |
| K963645 | armkel | HERPES GROUP IGG ELISA TEST SYSTEM | February 4, 1997 |
| K963282 | quest intl | SERAQUEST HSV IGG | January 22, 1997 |
| K950670 | diagnostic products | IMMULITE HERPES I AND II IGG | June 21, 1996 |
| K953839 | meridian diagnostics | PREMIER HSV PLUS | May 23, 1996 |
| K925208 | ortho diagnostic systems | ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION | December 28, 1992 |
| K922333 | baxter diagnostics | BARTELS HERPES SIMPLEX VIRUS 2 IGM EIA | December 15, 1992 |
| K922334 | baxter diagnostics | BARTELS HERPES SIMPLEX VIRUS 1 IGM EIA | December 15, 1992 |
| K922758 | gull laboratories | HSV-1 IGM ELISA TEST -- MODIFICATION | October 5, 1992 |
| K922759 | gull laboratories | HSV-2 IGM ELISA TEST--MODIFICATION | October 5, 1992 |
| K922583 | baxter diagnostics | BARTELS HERPES SIMPLEX VIRUS 2 IGG EIA | September 28, 1992 |