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

System, Test, Anticardiolipin Immunological (MID) (3) Enzyme Linked Immunoabsorbent Assay, Rubella (LFX) (2) System, Test, Thyroid Autoantibody (JZO) (2) Test System, Antineutrophil Cytoplasmic Antibodies (Anca) (MOB) (2) Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster (LFY) (1)

Premarket Exempt

No Yes

Clear

Diamedix - 00817273020204 Catalog Number :

Device Description : "720-370 Rubella IgM Test Kit"

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : LFX

Prescription Use : No

Device Count : 1

Diamedix - 00817273020211 Catalog Number :

Device Description : "720-380 VZV IgG Test Kit"

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : LFX

Prescription Use : No

Device Count : 1

Diamedix - 00817273020228 Catalog Number :

Device Description : "720-400 anti-Cardiolipin IgG/IgM Test Kit"

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : LFY

Prescription Use : No

Device Count : 1

Diamedix - 00817273020235 Catalog Number :

Device Description : "720-420 anti-Cardiolipin IgATest Kit"

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : MID

Prescription Use : No

Device Count : 1

Diamedix - 00817273020242 Catalog Number :

Device Description : "720-430 anti-MPO (P-ANCA) IgG Test Kit"

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : MID

Prescription Use : No

Device Count : 1

Diamedix - 00817273020259 Catalog Number :

Device Description : "720-440 anti-PR-3 (C-ANCA) IgG Test Kit"

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : MOB

Prescription Use : No

Device Count : 1

Diamedix - 00817273020266 Catalog Number :

Device Description : "720-450 anti-TPO IgG Test Kit"

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : MOB

Prescription Use : No

Device Count : 1

Diamedix - 00817273020273 Catalog Number :

Device Description : "720-460 anti-TG IgG Test Kit"

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : JZO

Prescription Use : No

Device Count : 1

Diamedix - 00817273020280 Catalog Number :

Device Description : "720-480 anti-Cardiolipin Screen"

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : JZO

Prescription Use : No

Device Count : 1

Diamedix - 00817273020297 Catalog Number :

Device Description : "720-520 Measles IgG Test Kit"

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : MID

Prescription Use : No

Device Count : 1

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