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

Protein, Complement, Antigen, Antiserum, Control (DHL) (4) Analyzer, Chemistry, Micro, For Clinical Use (JJF) (2) Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. (LJZ) (1) System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) (MSV) (1)

Premarket Exempt

No Yes

Clear

Diamedix - 00817273020402 Catalog Number :

Device Description : "720-830 anti-β2 Glycoprotein I IgG/IgM Test Kit"

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : MSV

Prescription Use : No

Device Count : 1

Diamedix - 00817273020419 Catalog Number :

Device Description : "720-850 Mycoplasma IgG Test Kit"

Device Class : 1

Duns Number: 151765328

Premarket Exempt : Yes

Product Code : LJZ

Prescription Use : No

Device Count : 1

Diamedix - 00817273020426 Catalog Number :

Device Description : "789-001 EZ Complement Cells"

Device Class : 1

Duns Number: 151765328

Premarket Exempt : No

Product Code : DHL

Prescription Use : No

Device Count : 1

Diamedix - 00817273020433 Catalog Number :

Device Description : "789-006 EZ Complement Reference Serum"

Device Class : 1

Duns Number: 151765328

Premarket Exempt : Yes

Product Code : DHL

Prescription Use : No

Device Count : 1

Diamedix - 00817273020440 Catalog Number :

Device Description : "789-008 EZ Complement Low Control"

Device Class : 1

Duns Number: 151765328

Premarket Exempt : Yes

Product Code : DHL

Prescription Use : No

Device Count : 1

Diamedix - 00817273020457 Catalog Number :

Device Description : "789-009 EZ Complement High Control"

Device Class : 1

Duns Number: 151765328

Premarket Exempt : Yes

Product Code : DHL

Prescription Use : No

Device Count : 1

Diamedix - 00817273020464 Catalog Number :

Device Description : MAGO Plus chemistry analyzer

Device Class : 1

Duns Number: 151765328

Premarket Exempt : No

Product Code : JJF

Prescription Use : No

Device Count : 1

Diamedix - 00817273020471 Catalog Number :

Device Description : Mago 4S Anayzer

Device Class : 1

Duns Number: 151765328

Premarket Exempt : No

Product Code : JJF

Prescription Use : No

Device Count : 1

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