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

Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control

21 CFR 866.5130 / Immunology
FDA source (opens on fda.gov)

DEI is the FDA product code for Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5130. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DEI
Device name
Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control
Regulation
21 CFR 866.5130
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
2
Ingested recalls
0

Clearances, product code DEI

By decision year
2 clearances under product code DEI with a decision year between 1977 and 1984, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DEI by decision year
YearClearances
19771
19841

Applicants with the most clearances

Product code DEI
Applicants holding the most 510(k) clearances under product code DEI
ApplicantClearances
Intl. Diagnostic Technology1
Kallestad Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code DEI.