GTJ · Class II · 21 CFR 866.3390

FDA Product Code GTJ: Antisera, All Groups, N. Meningitidis

Leading manufacturers include Wellcome Diagnostics, Armkel, LLC and Bd Becton Dickinson Vacutainer Systems Preanalytic.

Total

Cleared

118d

Avg days

1977

Since

FDA 510(k) Cleared Antisera, All Groups, N. Meningitidis Devices (Product Code GTJ)

16 devices

1–16 of 16

Cleared May 30, 1996

DIRECTIGEN MENINGITIS COMBO TEST

K952791

Bd Becton Dickinson Vacutainer Systems Preanalytic

Microbiology · 346d

Cleared Mar 23, 1992

DIRECTIGEN MENINGITIS COMBO TEST KIT

K915330

Bd Becton Dickinson Vacutainer Systems Preanalytic

Microbiology · 118d

Cleared Aug 12, 1991

SLIDEX MENINGITE-KIT 5

BACTIGEN(R) N. MENINGITIDIS

WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24

WELLCOGEN BACTERIAL ANTIGEN KIT

WILLCOGEN MENINGITIDIS KIT ZL25

MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51

DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST

K844407

Bd Becton Dickinson Vacutainer Systems Preanalytic

Microbiology · 73d

Cleared Jul 06, 1984

BACTIGEN - N.MENNINIGITIDIS TEST

WELLCOGEN N. MENINGITIDIS A,C,Y W135

BACTIGEN-N. MENINGITIDIS

PHADEBACT CSF TEST 20

AGGLUTINATING SERUM W135

K771562

Burroughs Wellcome Co.

Immunology · 10d

FDA Product Code GTJ: Antisera, All Groups, N. Meningitidis

FDA 510(k) Cleared Antisera, All Groups, N. Meningitidis Devices (Product Code GTJ)

About Product Code GTJ - Regulatory Context

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