Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
FDA product code LJM · 109 cleared devices
Class 2
Immunology
- Regulation
- 21 CFR 866.5100
- Review panel
- IM
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1982-10-08 – 2018-11-27
LJM
1985-08-01
LJM
1985-07-10
ANA/LITE-HEP-2 TEST SYSTEM
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LJM
1985-07-10
ANA/LITE-RL TEST SYSTEM
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LJM
1984-11-01
DNA STAT TEST KIT
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LJM
1984-10-25
ADP ANA APPLEZYME
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LJM
1984-09-20
AMIZYME-ANDNA TEST KIT
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LJM
1984-09-20
AMIZYME-ANA TEST KIT
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LJM
1983-11-21
ENZYME ANA TEST SYSTEM
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LJM
1982-10-08
HISTIMUNE ENZYME-ANA TEST
View details →No matching devices.
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