EMD Millipore Corporation

Address:400 Summit Drive,Burlington,MA,01803,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Antisera, Fluorescent, Human Metapneumovirus (OMG) (2) Antisera, Conjugated Fluorescent, Cytomegalovirus (LIN) (2) Antigen, Cf, (Including Cf Control), Varicella-Zoster (GQW) (2) Pneumocystis Carinii (LYF) (1) Antisera, Fluorescent, Herpesvirus Hominis 1,2 (GQL) (1) Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6 (GNM) (1) Antiserum, Cf, Varicella-Zoster (GQX) (1)

Premarket Exempt

No Yes

Clear

Light Diagnostics HSV 1 & 2 Control Slides (5 Pack) - 04053252278679 Catalog Number : 5093-5

Device Description : Light Diagnostics HSV 1 & 2 Control Slides (5 Pack)

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : GQL

Prescription Use : No

Device Count : 1

Light Diagnostics hMPV DFA Reagent - 04053252279362 Catalog Number : 5091

Device Description : Light Diagnostics hMPV DFA Reagent

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : OMG

Prescription Use : No

Device Count : 1

Light Diagnostics CMV DFA Reagent - 04053252282089 Catalog Number : 5090

Device Description : Light Diagnostics CMV DFA Reagent

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : LIN

Prescription Use : No

Device Count : 1

Light Diagnostics™ Human Metapneumovirus Direct Immunofluorescence Assay - 04053252282133 Catalog Number : 3124

Device Description : Human Metapneumovirus DFA Kit

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : OMG

Prescription Use : No

Device Count : 1

Light Diagnostics VZV Control Slides (5 pack) - 04053252285547 Catalog Number : 5088-5

Device Description : Light Diagnostics VZV Control Slides (5 pack)

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : GQX

Prescription Use : No

Device Count : 1

Light Diagnostics™ CMV DFA Kit - 04053252368745 Catalog Number : 3245

Device Description : CMV DFA Kit

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : LIN

Prescription Use : No

Device Count : 1

Light Diagnostics SimulFluor HSV/VZV Reagent - 04053252370960 Catalog Number : 5235

Device Description : SimulFluor HSV/VZV Reagent

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : GQW

Prescription Use : No

Device Count : 1

Light Diagnostics™ Simulfluor® HSV / VZV DFA - 04053252371745 Catalog Number : 3295

Device Description : Simulfluor HSV / VZV DFA Kit

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : GQW

Prescription Use : No

Device Count : 1

Light Diagnostics™ Pneumocystis Carinii DFA - 04053252401121 Catalog Number : 3195

Device Description : PCP DFA Kit

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : LYF

Prescription Use : No

Device Count : 1

Light Diagnostics ™ Coxsackievirus B6 Monoclonal Antibody - 04053252472985 Catalog Number : 3309

Device Description : Coxsackievirus B6 Monoclonal Antibody

Device Class : 1

Duns Number: 829517072

Premarket Exempt : No

Product Code : GNM

Prescription Use : No

Device Count : 1

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