|
Device |
test, qualitative, for hla, non-diagnostic |
Product Code | MZI |
Device Class |
Unclassified
|
Premarket Reviews |
Manufacturer | Decision |
BIOFORTUNA LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GEN-PROBE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GEN-PROBE GTI DIAGNOSTICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GENETIC TESTING INSTITUTE, INC. (GTI) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMMUCOR GTI DIAGNOSTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
IMMUCOR TRANSPLANT DIAGNOSTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
1. BK130075 Test, Qualitative, for HLA, Non-Diagnostic
|
2. BK150302 Test, Qualitative, for HLA, Non-Diagnostic
|
3. BK150343 Test, Qualitative, for HLA, Non-Diagnostic
|
LIFE TECHNOLOGIES CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OLERUP SSP AB |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ONE LAMBDA, INC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ONE LAMBDA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
TEPNEL LIFECODES CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TEXAS BIOGENE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|