Product code LJB— Microbiology
BARTELS RUBEOLA IGG EIA
- Classification name
- Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
- Device class
- Class 1
- Regulation
- 21 CFR 866.3520
- Advisory panel
- Microbiology
- Total cleared
- 11
- First cleared
- Most recent
FDA classification definition
“The qualitative detection of measles specific IgG antibodies in serum or plasma.”
Market context for product code LJB
FDA has cleared devices under product code LJB between 1982 and 1998, filed by 8 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1998
- 1997
- 1992
- 1991
- 1990
- 1989
- 1988
- 1982
Top applicants under product code LJB
Recent clearances under product code LJB
- K974552 — DIAMEDIX IS-MEASLES IGG TEST SYSTEM
- K971620 — QUANTA LITE RUBEOLA (MEASLES) IGG
- K922330 — BARTELS RUBEOLA IGG EIA
- K922335 — BARTELS RUBEOLA IGM EIA
- K910290 — VIRATEST-DIA(TM) MEASLES (RUBEOLA)
- K904083 — RUBEOLA IGM ELISA TEST
- K903961 — MEASLES IGG MICROASSAY
- K904854 — RUBEOLA IGG ELISA TEST
- K891990 — RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600
- K873925 — VIRGO(TM) MEASLES IGG ELISA
- K821762 — MEASELISA TEST KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.