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

FERRITIN, ANTIGEN, ANTISERUM, CONTROL (DBF) (1) IGE, ANTIGEN, ANTISERUM, CONTROL (DGC) (1) KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER (LCX) (1) RADIOASSAY, TRIIODOTHYRONINE UPTAKE (KHQ) (1) RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE (CFL) (1) RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) (CFT) (1) RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE (JLW) (1) SYSTEM, TEST, RHEUMATOID FACTOR (DHR) (1) System, test, beta-2-microglobulin immunological (JZG) (1) Visual, pregnancy hCG, prescription use (JHI) (1)

Premarket Exempt

No Yes

Clear

Prolactin ELISA - 00840239017864 Catalog Number : EIA-1786

Device Description : The Prolactin ELISA is intended for the quantitative determination of prolactin The Prolactin ELISA is intended for the quantitative determination of prolactin in human serum. The assay is useful in the diagnosis and treatment of disorders of the anterior pituitary and hypothalamus.

Device Class : 1

Duns Number: 075150847

Premarket Exempt : Yes

Product Code : CFT

Prescription Use : Yes

Device Count : 1

Human Growth Hormone (HGH) ELISA - 00840239017871 Catalog Number : EIA-1787

Device Description : The HGH ELISA is intended for the quantitative determination of human growth hor The HGH ELISA is intended for the quantitative determination of human growth hormone (HGH) concentration in human serum.

Device Class : 1

Duns Number: 075150847

Premarket Exempt : Yes

Product Code : CFL

Prescription Use : Yes

Device Count : 1

Immunoglobulin E (IgE) ELISA - 00840239017888 Catalog Number : EIA-1788

Device Description : The DRG IgE ELISA is intended for the quantitative determination of immunoglobul The DRG IgE ELISA is intended for the quantitative determination of immunoglobulin E in human serum. This assay is to be used for the assessment of hypersensitive and allergic reactions in patients.

Device Class : 2

Duns Number: 075150847

Premarket Exempt : No

Product Code : DGC

Prescription Use : Yes

Device Count : 1

Beta-2 Microglobulin ELISA - 00840239017895 Catalog Number : EIA-1789

Device Description : The Beta-2 Microglobulin ELISA is intended for the quantitative determination of The Beta-2 Microglobulin ELISA is intended for the quantitative determination of ß2-microglobulin in human serum.

Device Class : 2

Duns Number: 075150847

Premarket Exempt : No

Product Code : JZG

Prescription Use : Yes

Device Count : 1

TSH (ultrasensitive) ELISA - 00840239017901 Catalog Number : EIA-1790

Device Description : For the quantitative determination of thyroid stimulating hormone (TSH) concentr For the quantitative determination of thyroid stimulating hormone (TSH) concentration in human serum. The assay is useful in the diagnosis of thyroid or pituitary disorders.

Device Class : 2

Duns Number: 075150847

Premarket Exempt : No

Product Code : JLW

Prescription Use : No

Device Count : 1

Ferritin ELISA - 00840239018724 Catalog Number : EIA-1872

Device Description : The Ferritin ELISA is intended for the quantitative determination of ferritin in The Ferritin ELISA is intended for the quantitative determination of ferritin in human serum. This assay is to be used in the diagnosis of diseases affecting iron metabolism.

Device Class : 2

Duns Number: 075150847

Premarket Exempt : No

Product Code : DBF

Prescription Use : No

Device Count : 1

RF IgM (Rheumatoid Factor) ELISA - 00840239027757 Catalog Number : EIA-2775

Device Description : The DRG Rheumatoid Factor (RF) IgM ELISA test system is intended for the qualita The DRG Rheumatoid Factor (RF) IgM ELISA test system is intended for the qualitative and semi-quantitative detection of RF IgM-class antibody in human sera. The test system is intended to be used as an aid in the diagnosis of rheumatoid arthritis.

Device Class : 2

Duns Number: 075150847

Premarket Exempt : No

Product Code : DHR

Prescription Use : No

Device Count : 1

HCG dipstick Test - 00840239028181 Catalog Number : RAP-2818

Device Description : This is a test for the qualitative detection of human Chorionic Gonadotropin (HC This is a test for the qualitative detection of human Chorionic Gonadotropin (HCG) in urine.

Device Class : 2

Duns Number: 075150847

Premarket Exempt : No

Product Code : JHI

Prescription Use : No

Device Count : 1

HCG midstream Test - 00840239028228 Catalog Number : RAP-2822

Device Description : This is a test for the qualitative detection of human Chorionic Gonadotropin (HC This is a test for the qualitative detection of human Chorionic Gonadotropin (HCG) in urine.

Device Class : 2

Duns Number: 075150847

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

T3-Uptake ELISA - 00840239032676 Catalog Number : EIA-3267

Device Description : The measurement of the total amount of binding sites available for the Thyroid H The measurement of the total amount of binding sites available for the Thyroid Hormones in human serum or plasma by a microplate enzyme Immunoassay.

Device Class : 2

Duns Number: 075150847

Premarket Exempt : No

Product Code : KHQ

Prescription Use : No

Device Count : 1

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