Ramco Laboratories, Inc.

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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

ANTIGEN, ID, CANDIDA ALBICANS (LHK) (4) FERRITIN, ANTIGEN, ANTISERUM, CONTROL (DBF) (1) IMMUNOCHEMICAL, TRANSFERRIN (JNM) (1) TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY (GGP) (1)

Premarket Exempt

Clear

Spectro Ferritin MT - 08600000686017 Catalog Number : S-22

Device Description : ELISA-ferritin

Device Class : 2

Duns Number: 082013897

Premarket Exempt : No

Product Code : DBF

Prescription Use : No

Device Count : 1

Cand-Tec - 08600000686024 Catalog Number : CO3/5

Device Description : Candida Detection

Device Class : 2

Duns Number: 082013897

Premarket Exempt : No

Product Code : LHK

Prescription Use : No

Device Count : 1

TfR - 08600000686031 Catalog Number : TFC-94

Device Description : ELISA- TfR

Device Class : 2

Duns Number: 082013897

Premarket Exempt : No

Product Code : JNM

Prescription Use : No

Device Count : 1

VFE - 08600000686048 Catalog Number : VE-98

Device Description : EIA-VON WILLEBR.

Device Class : 2

Duns Number: 082013897

Premarket Exempt : No

Product Code : GGP

Prescription Use : No

Device Count : 1

Cand-Tec - 18600000686021 Catalog Number : CO3/1

Device Description : Candida Detection

Device Class : 2

Duns Number: 082013897

Premarket Exempt : No

Product Code : LHK

Prescription Use : No

Device Count : 1

Cand-Tec - 28600000686028 Catalog Number : CO3/2

Device Description : Candida Detection

Device Class : 2

Duns Number: 082013897

Premarket Exempt : No

Product Code : LHK

Prescription Use : No

Device Count : 1

Cand-Tec - 78600000686023 Catalog Number : CO3/7

Device Description : Candida Detection

Device Class : 2

Duns Number: 082013897

Premarket Exempt : No

Product Code : LHK

Prescription Use : No

Device Count : 1

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