Product code GTJ— Microbiology
AGGLUTINATING SERUM W135
- Classification name
- Antisera, All Groups, N. Meningitidis
- Device class
- Class 2
- Regulation
- 21 CFR 866.3390
- Advisory panel
- Microbiology
- Total cleared
- 16
- First cleared
- Most recent
Market context for product code GTJ
FDA has cleared devices under product code GTJ between 1977 and 1996, filed by 7 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
- 1996
- 1992
- 1991
- 1989
- 1987
- 1986
- 1985
- 1984
- 1983
- 1982
- 1977
Top applicants under product code GTJ
Recent clearances under product code GTJ
- K952791 — DIRECTIGEN MENINGITIS COMBO TEST
- K915330 — DIRECTIGEN MENINGITIS COMBO TEST KIT
- K910210 — SLIDEX MENINGITE-KIT 5
- K885004 — BACTIGEN(R) N. MENINGITIDIS
- K870089 — IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT
- K854851 — WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24
- K854852 — WELLCOGEN BACTERIAL ANTIGEN KIT
- K844999 — PHADEBACT CSF TEST
- K851691 — WILLCOGEN MENINGITIDIS KIT ZL25
- K844762 — MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51
- K844407 — DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST
- K841907 — BACTIGEN - N.MENNINIGITIDIS TEST
- K833063 — WELLCOGEN N. MENINGITIDIS A,C,Y W135
- K823880 — BACTIGEN-N. MENINGITIDIS
- K822810 — PHADEBACT CSF TEST 20
- K771562 — AGGLUTINATING SERUM W135
Data sourced from openFDA. This site is unofficial and independent of the FDA.