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

Test system, nicotine, cotinine, metabolites (MRS) (3) RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE) (JKC) (1) RADIOIMMUNOASSAY, ESTRONE (CGF) (1) RADIOIMMUNOASSAY, PREGNENOLONE (JNG) (1) ELISA, TRICHINELLA SPIRALIS (MDT) (1) RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE (CDP) (1) REAGENT, RICKETTSIA SEROLOGICAL (LSQ) (1) RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE (JLW) (1)

Premarket Exempt

No Yes

Clear

DHEA-S ELISA - 00840239046529 Catalog Number : CLA-4652

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

Device Class : 1

Duns Number: 075150847

Premarket Exempt : Yes

Product Code : JKC

Prescription Use : Yes

Device Count : 1

Estrone Serum ELISA - 00840239046543 Catalog Number : CLA-4654

Device Description : For the quantitative determination of Estrone in human saliva by a chemiluminesc For the quantitative determination of Estrone in human saliva by a chemiluminescence immunoassay.

Device Class : 1

Duns Number: 075150847

Premarket Exempt : Yes

Product Code : CGF

Prescription Use : Yes

Device Count : 1

Pregnenolone ELISA - 00840239049124 Catalog Number : EIA-4912

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

Device Class : 1

Duns Number: 075150847

Premarket Exempt : Yes

Product Code : JNG

Prescription Use : Yes

Device Count : 1

T3-Uptake ELISA - 00840239052667 Catalog Number : EIA-5266

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 : Yes

Product Code : JLW

Prescription Use : Yes

Device Count : 1

Free Triiodothyronine (fT3) ELISA - 00840239052773 Catalog Number : EIA-5277

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

Rickettsia IgG ELISA - 00840239052971 Catalog Number : EIA-5297

Device Description : The Spotted Fever Group Rickettsia IgG ELISA is intended for the detection of hu The Spotted Fever Group Rickettsia IgG ELISA is intended for the detection of human IgG class antibody to Spotted Fever Group Rickettsia, to be used as an aid in the diagnosis of human infection by these pathogens.

Device Class : 1

Duns Number: 075150847

Premarket Exempt : Yes

Product Code : LSQ

Prescription Use : Yes

Device Count : 1

Cotinine direct (serum/urine) ELISA (96 well) - 00840239054968 Catalog Number : EIA-5496

Device Description : The Cotinine direct (Serum/Urine) ELISA is a specific and sensitive in-vitro tes The Cotinine direct (Serum/Urine) ELISA is a specific and sensitive in-vitro test to detect the presence of Cotinine in serum and urine.

Device Class : 1

Duns Number: 075150847

Premarket Exempt : Yes

Product Code : MRS

Prescription Use : Yes

Device Count : 1

Cotinine direct (serum/urine) ELISA (480 well) - 00840239054975 Catalog Number : EIA-5497

Device Class : 1

Duns Number: 075150847

Premarket Exempt : Yes

Product Code : MRS

Prescription Use : Yes

Device Count : 1

Ascaris IgG ELISA - 00840239058546 Catalog Number : EIA-5854

Device Description : For the qualitative screening of serum or plasma IgG antibodies to Ascaris using For the qualitative screening of serum or plasma IgG antibodies to Ascaris using an Enzyme Linked Immunoabsorbant Assay (ELISA) technique.

Device Class : 1

Duns Number: 075150847

Premarket Exempt : Yes

Product Code : MDT

Prescription Use : Yes

Device Count : 1

Cotinine ELISA - 00840239059178 Catalog Number : EIA-5917

Device Description : The Cotinine ELISA Kit is intended for the measurement of Cotinine in serum, urine.

Device Class : 1

Duns Number: 075150847

Premarket Exempt : Yes

Product Code : MRS

Prescription Use : Yes

Device Count : 1

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