Company ยท US
Mrl Diagnostics
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2000. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LSR | Reagent, Borrelia Serological Reagent | 2 |
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 1 |
| LJN | Antibody Igm, If, Epstein-Barr Virus | 1 |
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | 1 |
| MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 1 |
| MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 14, 2000 | K000238 | HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G Mrl Diagnostics | LGC |
| Feb 9, 2000 | K993754 | HSV-1 ELISA IGG, MODEL EL0910G Mrl Diagnostics | MXJ |
| Feb 1, 2000 | K993724 | HSV-2 ELISA IGG, MODEL EL0920G Mrl Diagnostics | MYF |
| Jun 1, 1998 | K971007 | LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M) Mrl Diagnostics | LSR |
| Jun 1, 1998 | K971006 | LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G) Mrl Diagnostics | LSR |
| Jul 21, 1995 | K946353 | EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY Mrl Diagnostics | LLM |
| Apr 26, 1994 | K931520 | EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY Mrl Diagnostics | LJN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||