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GRA – Antiserum, Fluorescent, Mumps Virus
Antiserum, Fluorescent, Mumps Virus
FDA product code
GRA
· Class I (low risk) · 21 CFR 866.3380 ·
Microbiology
3
510(k) clearances
0
PMA approvals
0
recalls
Manufacturers
Flow Laboratories, Inc.
1
Electro-Nucleonics Laboratories, Inc.
1
Bion Ent., Ltd.
1
510(k) clearances
510(k)
Device
Applicant
Decision
K894624
Mumps Virus
GRA · Traditional
Bion Ent., Ltd.
10/16/1989
SE
K822826
Antibody to Mumps Virus Ifa Test
GRA · Traditional
Electro-Nucleonics Laboratories, Inc.
12/03/1982
SE
K770216
Viral Antisera, Fluorescein Labeled
GRA · Traditional
Flow Laboratories, Inc.
03/01/1977
SE