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) (3) Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (LGD) (2) Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific (LGC) (1) Antigen, Iha, Cytomegalovirus (LJO) (1) Intestinal Splinting Tubes (LCG) (1) Enzyme Linked Immunoabsorbent Assay, Rubella (LFX) (1) Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (LFZ) (1)

Premarket Exempt

No Yes

Clear

Diamedix - 00817273020105 Catalog Number :

Device Description : "720-270 anti-SM/RNP Test Kit"

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : LLL

Prescription Use : No

Device Count : 1

Diamedix - 00817273020112 Catalog Number :

Device Description : "720-280 anti-Scl-70 Test Kit"

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : LLL

Prescription Use : No

Device Count : 1

Diamedix - 00817273020129 Catalog Number :

Device Description : "720-290 anti-Jo-1 Test Kit"

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : LLL

Prescription Use : No

Device Count : 1

Diamedix - 00817273020136 Catalog Number :

Device Description : "720-300 Toxoplasma IgG Test Kit"

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : LGD

Prescription Use : No

Device Count : 1

Diamedix - 00817273020143 Catalog Number :

Device Description : "720-310 Toxoplasma IgM Test Kit"

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : LGD

Prescription Use : No

Device Count : 1

Diamedix - 00817273020150 Catalog Number :

Device Description : "720-320 CMV IgG Test Kit"

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : LFZ

Prescription Use : No

Device Count : 1

Diamedix - 00817273020167 Catalog Number :

Device Description : "720-330 CMV IgM Test Kit"

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : LJO

Prescription Use : No

Device Count : 1

Diamedix - 00817273020174 Catalog Number :

Device Description : "720-340 HSV 1&2 IgG Test Kit"

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : LGC

Prescription Use : No

Device Count : 1

Diamedix - 00817273020181 Catalog Number :

Device Description : "720-350 HSV 1&2 IgM Test Kit"

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : LCG

Prescription Use : No

Device Count : 1

Diamedix - 00817273020198 Catalog Number :

Device Description : "720-360 Rubella IgG Test Kit"

Device Class : 2

Duns Number: 151765328

Premarket Exempt : No

Product Code : LFX

Prescription Use : No

Device Count : 1

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