|
FDA-
Approved Tests for Hepatitis B
Antibody
to Hepatitis B Surface Antigen (HBsAg Assay)
|
Tradename(s)
|
Format
|
Sample
|
Use
|
Manufacturer
|
Approval
Date
|
| Auszyme
Monoclonal |
EIA |
Serum
/ Plasma |
Donor
Screen & Conf. Kit |
Abbott
Laboratories
Abbott Park, IL
US License 0043 |
4/1/1985 |
| Genetic
Systems HBsAg EIA 2.0 |
EIA |
Serum
/ Plasma / Cadaveric Serum |
Donor
Screen & Conf. Kit |
Bio-Rad
Laboratories Blood Virus Division
Redmond, WA
US License 1109 |
12/28/1999 |
| Ortho
Antibody to HBsAg ELISA Test System 2 |
EIA |
Serum
/ Plasma |
Donor
Screen & Conf. Kit |
Ortho-Clinical
Diagnostics, Inc.
Raritan, NJ
US License 1236 |
7/23/1971 |
| AUK-3 |
RIA |
Serum
/ Plasma |
Donor
Screen & Conf. Kit |
DiaSorin
s.r.l.
Saluggia, Italy
US License 1257 |
5/9/1986 |
| ETI-MAK-2 |
EIA |
Serum
/ Plasma |
Donor
Screen & Conf. Kit |
DiaSorin
s.r.l. |
4/18/1995 |
Hepatitis B Surface Antigen (Anti-HBs
Assay)
|
Tradename(s)
|
Format
|
Sample
|
Use
|
Manufacturer
|
Approval
Date
|
| Ausab
|
RIA
|
Serum
/ Plasma |
Anti-HBs
|
Abbott
Laboratories
Abbott Park, IL
US License 0043 |
2/5/1975
|
| Ausab
EIA |
EIA
|
Serum
/ Plasma |
Anti-HBs
|
Abbott
Laboratories |
11/18/1982
|
| AB-AUK-3
|
RIA
|
Serum
/ Plasma |
Anti-HBs
|
DiaSorin
s.r.l.
Saluggia, Italy
US License 1257 |
6/27/1989
|
| ETI-AB-AUK
|
EIA
|
Serum
/ Plasma |
Anti-HBs
|
DiaSorin
s.r.l. |
4/18/1995
|
Hepatitis B Virus Core Antigen (Anti-HBc
Assay)
|
Tradename(s)
|
Format
|
Sample
|
Use
|
Manufacturer
|
Approval
Date
|
| Corzyme
|
EIA
|
Serum
/ Plasma |
Donor
Screen |
Abbott
Laboratories
Abbott Park, IL
US License 0043 |
3/19/1991
|
| Ortho
HBc ELISA Test System |
EIA
|
Serum
/ Plasma |
Donor
Screen |
Ortho-Clinical
Diagnostics, Inc.
Raritan, NJ
US License 1236 |
4/18/1991
|
| AB-COREK
|
RIA
|
Serum
/ Plasma |
Donor
Screen |
DiaSorin
s.r.l.
Saluggia, Italy
US License 1257 |
3/19/1991
|
| ETI-AB-COREK
|
EIA
|
Serum
/ Plasma |
Donor
Screen |
DiaSorin
s.r.l. |
3/19/1991
|
Source
US Food and Drug Administration (FDA)
|
|
