Product code DDB— Immunology

FDA has cleared 19 devices under product code DDB between 1977 and 2017, filed by 15 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.

• 20171 clearance
• 20131 clearance
• 20061 clearance
• 19971 clearance
• 19911 clearance
• 19891 clearance
• 19861 clearance
• 19853 clearances
• 19821 clearance
• 19811 clearance
• 19801 clearance
• 19793 clearances
• 19782 clearances
• 19771 clearance

• Kent Laboratories, Inc.3 clearances
• Kallestad Laboratories, Inc.2 clearances
• Beckman Instruments, Inc.2 clearances
• The Binding Site, Ltd.1 clearance
• The Binding Site Group , Ltd.1 clearance
• Sigma Diagnostics, Inc.1 clearance
• Kallestad Diag, A Div. of Erbamont, Inc.1 clearance
• J.T. Baker Chemical Co.1 clearance
• Icl Scientific1 clearance
• Hyland Therapeutic Div., Travenol Laboratories1 clearance

• K161508 — CeruloplasminBeckman Coulter Ireland, Inc.·2017-01-09
• K122965 — HUMAN CAERULOPLASMIN KITThe Binding Site Group , Ltd.·2013-06-03
• K053074 — N ANTISERA TO HUMAN CERULOPLASMINDade Behring, Inc.·2006-03-16
• K964762 — IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENTBeckman Instruments, Inc.·1997-04-25
• K913668 — CAERULOPLASMIN IMMUNOLOGICAL NL TEST KITThe Binding Site, Ltd.·1991-12-20
• K895377 — QM300 CERULOPLASMIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.·1989-09-21
• K860138 — NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUMSigma Diagnostics, Inc.·1986-03-28
• K850682 — 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPLKent Laboratories, Inc.·1985-11-25
• K852247 — LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS)Behring Diagnostics, Inc.·1985-07-10
• K851283 — RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMINCooper Biomedical, Inc.·1985-05-23
• K823107 — QUANTIMETRIC 2 CERULOPLASMIN ASSAYKallestad Laboratories, Inc.·1982-11-16
• K812486 — IMMUNOGL. FRCT. OF RABBIT ANTISER.-CERULDako Corp.·1981-09-23
• K801661 — J.T. BAKER CERULOPLASMIN NEPHELOMETRICJ.T. Baker Chemical Co.·1980-09-16
• K790712 — ANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULIKent Laboratories, Inc.·1979-08-16
• K790714 — ANTISERUM TO HUMAN CERULOPLASMINKent Laboratories, Inc.·1979-08-16
• K791339 — HUMAN CERULOPLASMINBeckman Instruments, Inc.·1979-08-16
• K781024 — CERUOPLASMIN SERUM ANTI-HUMANIcl Scientific·1978-08-14
• K772255 — CERULOPLASMIN NEPHEL. ASSAYKallestad Laboratories, Inc.·1978-01-05
• K771795 — LAS-R CERULOPLASMIN TESTHyland Therapeutic Div., Travenol Laboratories·1977-11-14