AGILENT TECHNOLOGIES SINGAPORE PTE LTD

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Filters

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

IGA, ANTIGEN, ANTISERUM, CONTROL (CZP) (3) KAPPA, ANTIGEN, ANTISERUM, CONTROL (DFH) (2) LAMBDA, ANTIGEN, ANTISERUM, CONTROL (DEH) (2) IMMUNOCHEMICAL, LYSOZYME (MURAMIDASE) (JMR) (1) IMMUNOHISTOCHEMISTRY REAGENTS AND KITS (NJT) (1) WHOLE HUMAN SERUM, ANTIGEN, ANTISERUM, CONTROL (DGR) (1) IGG, ANTIGEN, ANTISERUM, CONTROL (DEW) (1) IGM (MU CHAIN SPECIFIC), ANTIGEN, ANTISERUM, CONTROL (DAO) (1)

Premarket Exempt

No Yes

Clear

Poly Rb A-Hu IgA - 05700572000617 Catalog Number :

Device Description : Polyclonal Rabbit Anti-Human IgA

Device Class : 2

Duns Number: 894671143

Premarket Exempt : No

Product Code : CZP

Prescription Use : No

Device Count : 1

Poly Rb A-Hu Lysozyme EC 3.2.1.17 - 05700572000686 Catalog Number :

Device Description : Polyclonal Rabbit Anti-Human Lysozyme EC 3.2.1.17

Device Class : 1

Duns Number: 894671143

Premarket Exempt : Yes

Product Code : JMR

Prescription Use : No

Device Count : 1

Poly Rb A-Hu Kappa Free LC - 05700572000693 Catalog Number :

Device Description : Polyclonal Rabbit Anti-Human Kappa Free Light Chains

Device Class : 2

Duns Number: 894671143

Premarket Exempt : Yes

Product Code : DFH

Prescription Use : No

Device Count : 1

Poly Rb A-Hu Lambda Free LC - 05700572000716 Catalog Number :

Device Description : Polyclonal Rabbit Anti-Human Lambda Free Light Chains

Device Class : 2

Duns Number: 894671143

Premarket Exempt : Yes

Product Code : DEH

Prescription Use : No

Device Count : 1

Poly Rb A-Hu IgA, IgG, IgM - 05700572000860 Catalog Number :

Device Description : Polyclonal Rabbit Anti-Human IgA, IgG, IgM

Device Class : 2

Duns Number: 894671143

Premarket Exempt : Yes

Product Code : DEW, CZP, DAO

Prescription Use : No

Device Count : 1

Poly Rb A-Hu Kappa LC - 05700572000884 Catalog Number :

Device Description : Polyclonal Rabbit Anti-Human Kappa Light Chains

Device Class : 2

Duns Number: 894671143

Premarket Exempt : No

Product Code : DFH

Prescription Use : No

Device Count : 1

Poly Rb A-Hu Lambda LC - 05700572000921 Catalog Number :

Device Description : Polyclonal Rabbit Anti-Human Lambda Light Chains

Device Class : 2

Duns Number: 894671143

Premarket Exempt : No

Product Code : DEH

Prescription Use : No

Device Count : 1

Poly Rb A-Hu Serum - 05700572000969 Catalog Number :

Device Description : Polyclonal Rabbit Anti-Human Serum

Device Class : 1

Duns Number: 894671143

Premarket Exempt : Yes

Product Code : DGR

Prescription Use : No

Device Count : 1

Poly Rb A-Hu Thyroglobulin - 05700572001089 Catalog Number :

Device Description : Polyclonal Rabbit Anti-Human Thyroglobulin

Device Class : 1

Duns Number: 894671143

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Poly Rb A-Hu IgA - 05700572001140 Catalog Number :

Device Description : Polyclonal Rabbit Anti-Human IgA

Device Class : 2

Duns Number: 894671143

Premarket Exempt : Yes

Product Code : CZP

Prescription Use : No

Device Count : 1

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