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

AMPLIFIER AND SIGNAL CONDITIONER, BIOPOTENTIAL (DRR) (1) C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL (DCK) (1) ENZYME LINKED IMMUNOABSORBENT ASSAY, MUMPS VIRUS (LJY) (1) Enzyme immunoassay, amphetamine (DKZ) (1) Enzyme linked immunoabsorbent assay, rubeola IgG (LJB) (1) INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) (JIR) (1) RADIOIMMUNOASSAY, CALCITONIN (JKR) (1) RADIOIMMUNOASSAY, ESTRONE (CGF) (1) RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE (CGJ) (1) RADIOIMMUNOASSAY, LUTEINIZING HORMONE (CEP) (1)

Premarket Exempt

No Yes

Clear

Calcitonin ELISA - 00840239036483 Catalog Number : EIA-3648

Device Description : The Calcitonin ELISA is intended for the quantitative determination of Calcitoni The Calcitonin ELISA is intended for the quantitative determination of Calcitonin in human serum.

Device Class : 2

Duns Number: 075150847

Premarket Exempt : No

Product Code : JKR

Prescription Use : Yes

Device Count : 1

Drugs of Abuse Five (5) Panel Test - 00840239037732 Catalog Number : RAP-3773

Device Description : The Drugs of Abuse (DOA-5) Panel Test is set up as a one step in-vitro test base The Drugs of Abuse (DOA-5) Panel Test is set up as a one step in-vitro test based on immunochromatography. It isdesigned for the qualitative determination of 5 drug substances, specifically Amphetamine, Benzodiazepine, Cocaine,Opiate, and Cannabinoid in human urine specimens.

Device Class : 2

Duns Number: 075150847

Premarket Exempt : No

Product Code : DKZ

Prescription Use : Yes

Device Count : 1

Measles Virus IgG ELISA - 00840239038449 Catalog Number : EIA-3844

Device Description : The Measles Virus IgG ELISA is intended for the qualitative determination of IgG The Measles Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Measles Virus in human serum or plasma (citrate, heparin).

Device Class : 1

Duns Number: 075150847

Premarket Exempt : Yes

Product Code : LJB

Prescription Use : No

Device Count : 1

Mumps Virus IgG ELISA - 00840239038463 Catalog Number : EIA-3846

Device Description : The Mumps Virus IgG ELISA is intended for the qualitative determination of IgG c The Mumps Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Mumps Virus in human serum or plasma (citrate, heparin).

Device Class : 1

Duns Number: 075150847

Premarket Exempt : Yes

Product Code : LJY

Prescription Use : No

Device Count : 1

Micro-Albumin ELISA - 00840239038814 Catalog Number : EIA-3881

Device Description : Micro-Albumin ELISA is a competitive test system for the quantitative measuremen Micro-Albumin ELISA is a competitive test system for the quantitative measurement of human albumin in urine.

Device Class : 1

Duns Number: 075150847

Premarket Exempt : No

Product Code : JIR

Prescription Use : No

Device Count : 1

C-Reactive Protein HS ELISA - 00840239039545 Catalog Number : EIA-3954

Device Description : The C-Reactive Protein HS ELISA is intended for the quantitative determination o The C-Reactive Protein HS ELISA is intended for the quantitative determination of C-reactive protein (CRP) in human serum.Enhanced sensitivity measurements of CRP can be useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.

Device Class : 2

Duns Number: 075150847

Premarket Exempt : No

Product Code : DCK

Prescription Use : No

Device Count : 1

Myoglobin ELISA - 00840239039552 Catalog Number : EIA-3955

Device Description : The Myoglobin ELISA is intended for the quantitative determination of myoglobin The Myoglobin ELISA is intended for the quantitative determination of myoglobin in human serum.

Device Class : 2

Duns Number: 075150847

Premarket Exempt : No

Product Code : DRR

Prescription Use : Yes

Device Count : 1

Estrone ELISA - 00840239040794 Catalog Number : EIA-4079

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

Device Class : 1

Duns Number: 075150847

Premarket Exempt : Yes

Product Code : CGF

Prescription Use : Yes

Device Count : 1

FSH ELISA - 00840239040985 Catalog Number : EIA-4098

Device Description : For the Quantitative Determination of Follicle Stimulating Hormone Concentration For the Quantitative Determination of Follicle Stimulating Hormone Concentration in Human Serum by a Microplate Enzyme Immunoassay, Colorimetric.

Device Class : 1

Duns Number: 075150847

Premarket Exempt : No

Product Code : CGJ

Prescription Use : Yes

Device Count : 1

LH ELISA - 00840239041036 Catalog Number : EIA-4103

Device Description : The Quantitative Determination of Luteinizing Hormone Concentration in Human Ser The Quantitative Determination of Luteinizing Hormone Concentration in Human Serum by a Microplate Enzyme Immunoassay, Colorimetric.

Device Class : 1

Duns Number: 075150847

Premarket Exempt : Yes

Product Code : CEP

Prescription Use : Yes

Device Count : 1

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