Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Visual, Pregnancy Hcg, Prescription Use

FDA classification

FDA Class 2 ·Visual, Pregnancy Hcg, Prescription Use

Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Kit, Test, Pregnancy, Hcg, Over The Counter

FDA classification

FDA Class 2 ·Kit, Test, Pregnancy, Hcg, Over The Counter

Needle, Phacoemulsification, Reprocessed

FDA classification

FDA Class 2 ·Needle, Phacoemulsification, Reprocessed

Assisted Reproduction Laminar Flow Workstation

FDA classification

FDA Class 2 ·Assisted Reproduction Laminar Flow Workstation

Accessory, Assisted Reproduction, Exempt

FDA classification

FDA Class 2 ·Accessory, Assisted Reproduction, Exempt

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·RIGID GAS PERMEABLE CONTACT LENSES

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·BOSTON(R) RXD(TM)(ITABISFLUOROFOCON A) BIFOCAL LEN

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·O-PERM F60 RGP CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·HYDROPERM (TM) RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OCUSIL(TM) CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OPTACRYL 60 - CLEAR

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·O-PERM F60 RGP CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OPTACRYL II BLUE

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·HYDROPERM (TM) RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOREX (TM) 600 (FLURSILFOCON A)

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OCUSIL(TM) CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OCUSIL(TM) CONTACT LENS