DRG International Inc

Address:841 Mountain Ave,Springfield,NJ,07081,US

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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

ANTIGENS, ALL, LEPTOSPIRA SPP. (GRY) (1) ELISA, TRICHINELLA SPIRALIS (MDT) (1) Enzyme immunoassay, non-radiolabeled, total thyroxine (KLI) (1) IMMUNOCHEMICAL, THYROGLOBULIN AUTOANTIBODY (JNL) (1) RADIOIMMUNOASSAY, FREE THYROXINE (CEC) (1) RADIOIMMUNOASSAY, PREGNENOLONE (JNG) (1) RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE (CDZ) (1) RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE (JLW) (1) RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE (CDP) (1) THYROGLOBULIN, ANTIGEN, ANTISERUM, CONTROL (DDC) (1)

Premarket Exempt

No Yes

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Free Triiodothyronine (fT3) ELISA - 00840239041074 Catalog Number : EIA-4107

Device Description : The Quantitative Determination of Free Triiodothyronine Concentration in Human S The Quantitative Determination of Free Triiodothyronine Concentration in Human Serum by a Microplate Enzyme Immunoassay.

Device Class : 2

Duns Number: 075150847

Premarket Exempt : Yes

Product Code : CDP

Prescription Use : Yes

Device Count : 1

Free Thyroxine (fT4) ELISA - 00840239041098 Catalog Number : EIA-4109

Device Description : The Quantitative Determination of Free Thyroxine Concentration in Human Serum or The Quantitative Determination of Free Thyroxine Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay.

Device Class : 2

Duns Number: 075150847

Premarket Exempt : No

Product Code : KLI

Prescription Use : Yes

Device Count : 1

Anti-Thyroglobulin (Anti-Tg) ELISA - 00840239041104 Catalog Number : EIA-4110

Device Description : The Quantitative Determination of Thyroglobulin (Tg) Autoantibodies in Human Ser The Quantitative Determination of Thyroglobulin (Tg) Autoantibodies in Human Serum or Plasma by a Microplate Enzyme Immunoassay, Colorimetric. Measurements of Tg autoantibodies may aid in the diagnosis of certain thyroid diseases such as Hashimoto’s and Grave’s as well as nontoxic goiter.

Device Class : 2

Duns Number: 075150847

Premarket Exempt : No

Product Code : DDC

Prescription Use : No

Device Count : 1

Thyrotropin (TSH) ELISA - 00840239041111 Catalog Number : EIA-4111

Device Description : The Quantitative Determination of Thyrotropin Concentration in Human Serum by a The Quantitative Determination of Thyrotropin Concentration in Human Serum by a Microplate Immunoenzymometric assay.

Device Class : 2

Duns Number: 075150847

Premarket Exempt : No

Product Code : JLW

Prescription Use : Yes

Device Count : 1

Anti-Thyroid Peroxidase (Anti-TPO) ELISA - 00840239041142 Catalog Number : EIA-4114

Device Description : The Quantitative Determination of Thyroid Peroxidase (TPO) Autoantibodies in Hum The Quantitative Determination of Thyroid Peroxidase (TPO) Autoantibodies in Human Serum or Plasma by a Microplate Enzyme Immunoassay. Measurements of TPO autoantibodies may aid in the diagnosis of certain thyroid diseases such as Hashimoto’s and Grave’s as well as nontoxic goiter.

Device Class : 2

Duns Number: 075150847

Premarket Exempt : No

Product Code : JNL

Prescription Use : No

Device Count : 1

Pregnenolone Direct ELISA - 00840239041708 Catalog Number : EIA-4170

Device Description : For the direct quantitative determination of Pregnenolone by enzyme immunoassay For the direct quantitative determination of Pregnenolone by enzyme immunoassay in human serum.

Device Class : 1

Duns Number: 075150847

Premarket Exempt : Yes

Product Code : JNG

Prescription Use : Yes

Device Count : 1

Strongyloides IgG ELISA - 00840239042088 Catalog Number : EIA-4208

Device Description : The Strongyloides ELISA test is a qualitative enzyme immunoassay for the detecti The Strongyloides ELISA test is a qualitative enzyme immunoassay for the detection of antibodies to Strongyloides, in samples of human serum or plasma.

Device Class : 1

Duns Number: 075150847

Premarket Exempt : Yes

Product Code : MDT

Prescription Use : Yes

Device Count : 1

Leptopspira IgG ELISA - 00840239042453 Catalog Number : EIA-4245

Device Description : The Leptospira IgG ELISA test is an enzyme immunoassay for the detection of anti The Leptospira IgG ELISA test is an enzyme immunoassay for the detection of antibodies to Leptospira biflexa (serovar patoc 1) for the serological confirmation of infections in serum and plasma.

Device Class : 2

Duns Number: 075150847

Premarket Exempt : Yes

Product Code : GRY

Prescription Use : Yes

Device Count : 1

Free Thyroxine (fT4) ELISA - 00840239042668 Catalog Number : EIA-4266

Device Class : 2

Duns Number: 075150847

Premarket Exempt : No

Product Code : CEC

Prescription Use : Yes

Device Count : 1

Free Testosterone ELISA - 00840239046383 Catalog Number : EIA-4638

Device Description : For the direct quantitative determination of Free Testosterone by enzyme immunoa For the direct quantitative determination of Free Testosterone by enzyme immunoassay in human serum. For in vitro diagnostic use only.

Device Class : 1

Duns Number: 075150847

Premarket Exempt : No

Product Code : CDZ

Prescription Use : Yes

Device Count : 1

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