DIAMEDIX CORPORATION

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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

Extractable Antinuclear Antibody, Antigen And Control (LLL) (6) Antigen, Iha, Cytomegalovirus (LJO) (2) Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (LGD) (1) Helicobacter Pylori (LYR) (1)

Premarket Exempt

No Yes

Clear

Diamedix - 00817273020006 Catalog Number :

Device Description : Calibration Test Kit

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : LGD

Prescription Use : No

Device Count : 1

Diamedix - 00817273020013 Catalog Number :

Device Description : 251-035 ProbeClean Concentration Kit"

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : LJO

Prescription Use : No

Device Count : 1

Diamedix - 00817273020020 Catalog Number :

Device Description : "300-312A Toxoplasma IgM Capture Lyoph. Ag. Accessory Kit"

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : LJO

Prescription Use : No

Device Count : 1

Diamedix - 00817273020037 Catalog Number :

Device Description : 300-331A CMV IgM Capture Lyoph. Ag. Accessory Kit

Device Class : 1

Duns Number: 151765328

Premarket Exempt : No

Product Code : LYR

Prescription Use : No

Device Count : 1

Diamedix - 00817273020044 Catalog Number :

Device Description : "300-371A Rubella IgM Capture Lyoph. Ag. Accessory Kit"

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : LLL

Prescription Use : No

Device Count : 1

Diamedix - 00817273020051 Catalog Number :

Device Description : 720-130 H.pylori IgG Test Kit

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : LLL

Prescription Use : No

Device Count : 1

Diamedix - 00817273020068 Catalog Number :

Device Description : 720-230 ENA-6 Screen Test Kit

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : LLL

Prescription Use : No

Device Count : 1

Diamedix - 00817273020075 Catalog Number :

Device Description : 720-240 anti-SM Test Kit

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : LLL

Prescription Use : No

Device Count : 1

Diamedix - 00817273020082 Catalog Number :

Device Description : 720-250 anti-SSA Test Kit

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : LLL

Prescription Use : No

Device Count : 1

Diamedix - 00817273020099 Catalog Number :

Device Description : 720-260 anti-SSB Test Kit

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : LLL

Prescription Use : No

Device Count : 1

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