Product code GLZ— Microbiology
ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII
- Classification name
- Antigens, If, Toxoplasma Gondii
- Device class
- Class 2
- Regulation
- 21 CFR 866.3780
- Advisory panel
- Microbiology
- Total cleared
- 18
- First cleared
- Most recent
Market context for product code GLZ
FDA has cleared devices under product code GLZ between 1977 and 1993, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1993
- 1988
- 1985
- 1984
- 1983
- 1981
- 1980
- 1979
- 1978
- 1977
Top applicants under product code GLZ
Recent clearances under product code GLZ
- K924882 — TOXOPLASMA IGM IFA TEST SYSTEM
- K880007 — TOXO IGM TEST
- K850591 — FIAX TOXO-M ANTIBODIES TEST KIT
- K844287 — ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII
- K842664 — ANTI-TOXOPLASMA GONDII KIT
- K832900 — IMMUNOENZYME TEST SYS-DETECT-IGM ANTI
- K830869 — POLYCHACO INDIRECT IMMUNOFLUORESCENCE
- K811562 — TOXOPLASMOSIS TEST KIT
- K803134 — TOXOPLASMA GONDII SEROLOGICAL REAGENTS
- K801720 — TOXO BIO-BEAD TITRATION KIT
- K791611 — TOXO BIO-BEAD SCREEN KIT
- K791618 — TORCH BIO-BEAD SCREEN KIT
- K791571 — TOXOPLASMA ANTIBODY TEST SYSTEM
- K790464 — FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO
- K790360 — QUANTAZYME TOXOPLASMA
- K781549 — TOXELISA TEST KIT
- K780352 — IMMUNOZYME TOXOPLASMA ANTIBODY
- K772243 — TOXO TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.