Product code LIN— Microbiology
BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN
- Classification name
- Antisera, Conjugated Fluorescent, Cytomegalovirus
- Device class
- Class 2
- Regulation
- 21 CFR 866.3175
- Advisory panel
- Microbiology
- Total cleared
- 17
- First cleared
- Most recent
Market context for product code LIN
FDA has cleared devices under product code LIN between 1982 and 2008, filed by 13 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
- 2008
- 1999
- 1996
- 1994
- 1992
- 1991
- 1990
- 1989
- 1986
- 1985
- 1982
Top applicants under product code LIN
Recent clearances under product code LIN
- K081164 — D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT
- K983762 — NUCLISENS CMV PP67
- K991650 — CMV BRITE TURBO KIT
- K951821 — CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
- K951550 — CMV BRITE ANTIGENEMIA TEST KIT
- K934798 — PATHODX CYTOMEGALOVIRUS
- K921616 — CMV-VUE(TM) CMV ANTIGEN DETECTION KIT
- K912592 — CMV-EA MAB TEST
- K905257 — OPUS CMV TEST SYSTEM
- K904036 — BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN
- K894002 — CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY
- K893467 — CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST)
- K893468 — CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST)
- K860279 — CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT
- K843138 — CMV TEST
- K822606 — CYTOMEGALOVIRUS ANTOBODY IGG
- K820895 — CYLOMEGALOVIRUS DIRECT FLUORESCENT ANTI
Data sourced from openFDA. This site is unofficial and independent of the FDA.