Product code LRM— Immunology
3M ANTI-DSDNA FAST TEST
- Classification name
- Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Total cleared
- 29
- First cleared
- Most recent
Market context for product code LRM
FDA has cleared devices under product code LRM between 1987 and 2010, filed by 23 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2010
- 2009
- 2006
- 2004
- 2000
- 1999
- 1998
- 1997
- 1996
- 1995
- 1994
- 1992
- 1991
- 1990
- 1989
Top applicants under product code LRM
Recent clearances under product code LRM
- K101319 — IMMULISA DSDNA ANTIBODY ELISA
- K083381 — EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)
- K062183 — FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
- K040811 — VARELISA SSDNA ANTIBODIES, MODEL 14896
- K001900 — ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST
- K000477 — MDI DS-DNA TEST
- K994424 — DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM
- K993727 — BINDAZYME ANTI-DSDNA EIA KIT
- K984396 — LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213
- K983422 — THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET
- K980391 — SERAQUEST ANTI-DSDNA
- K974694 — IS-DSDNA TEST SYSTEM
- K962730 — HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY
- K952567 — AUTOSTATTMII ANTI-DSDNA
- K954893 — HYTEC AUTOMIMMUNE KIT (DS-DNA)
- K960091 — ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT
- K960182 — DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM
- K953671 — ORGEN TEC ANTI-DSDNA ELISA ASSAY
- K952055 — ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY
- K944334 — VARELISA COMBINED DNA ANTIBODIES EIA
- K950031 — VARELISA DSDNA ANTIBODIES (FARR VERSION)
- K940585 — SELISA ANTI-N DNA ANTIBODIES
- K923537 — ENCORE DS-DNA
- K913653 — 3M ANTI-DSDNA FAST TEST
- K912020 — ANTI-DNA MICROASSAY
- K902897 — UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE
- K893036 — ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS)
- K874191 — NDNA ANTIBODY TEST KIT
- K870903 — IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.