510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OBEClass II

Anti-Ss-A 52 Autoantibodies

21 CFR 866.5100 / Immunology
FDA source (opens on fda.gov)

OBE is the FDA product code for Anti-Ss-A 52 Autoantibodies, a class II device type, regulated under 21 CFR 866.5100. FDA's definition for this code reads: "The device is used for the detection, in human serum or plasma, of autoantibodies to SS-A 52. The detection of SS-A 52 autoantibodies may aid in the diagnosis of systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, polymyositis and dermatomyositis". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OBE
Device name
Anti-Ss-A 52 Autoantibodies
FDA definition
The device is used for the detection, in human serum or plasma, of autoantibodies to SS-A 52. The detection of SS-A 52 autoantibodies may aid in the diagnosis of systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code OBE

By decision year
3 clearances under product code OBE with a decision year between 2007 and 2026, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OBE by decision year
YearClearances
20071
20151
20261

Applicants with the most clearances

Product code OBE
Applicants holding the most 510(k) clearances under product code OBE
ApplicantClearances
Inova Diagnostics, Inc.2
Zeus Scientific LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code