AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Address:26 Keewaydin Drive,Salem,NH,03079,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

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) (JKC) (3) Radioimmunoassay, 17-Hydroxyprogesterone (JLX) (2) Radioimmunoassay, Pregnenolone (JNG) (1) Radioimmunoassay, Progesterone (JLS) (1) Radioimmunoassay, Testosterones And Dihydrotestosterone (CDZ) (1) Radioimmunoassay, Luteinizing Hormone (CEP) (1) Antigen, B. Pertussis (GOX) (1)

Premarket Exempt

No Yes

Clear

Dehydroepiandrosterone (DHEA) ELISA - B24211HEAHUE010 Catalog Number : 11-HEAHU-E01

Device Description : The Dehydroepiandrosterone ELISA is intended for the direct quantitative determi The Dehydroepiandrosterone ELISA is intended for the direct quantitative determination of DHEA by enzyme immunoassay in human serum.

Device Class : 1

Duns Number: 784143778

Premarket Exempt : Yes

Product Code : JKC

Prescription Use : Yes

Device Count : 1

Luteinizing Hormone (LH) ELISA - B24211LUTHUE010 Catalog Number : 11-LUTHU-E01

Device Description : Intended for the direct quantitative determination of Luteinizing Hormone by an Intended for the direct quantitative determination of Luteinizing Hormone by an enzyme immunoassay in human serum. For in vitro diagnostic use.

Device Class : 1

Duns Number: 784143778

Premarket Exempt : Yes

Product Code : CEP

Prescription Use : Yes

Device Count : 1

Pregnenolone ELISA - B24211PREHUE010 Catalog Number : 11-PREHU-E01

Device Description : Intended for the direct quantitative determination of Pregnenolone by enzyme imm Intended for the direct quantitative determination of Pregnenolone by enzyme immunoassay using human serum. For in vitro diagnostic use.

Device Class : 1

Duns Number: 784143778

Premarket Exempt : Yes

Product Code : JNG

Prescription Use : Yes

Device Count : 1

Progesterone ELISA - B24211PROHUE010 Catalog Number : 11-PROHU-E01

Device Description : Intended for the direct quantitative determination of Progesterone by enzyme imm Intended for the direct quantitative determination of Progesterone by enzyme immunoassay using human serum. For in vitro diagnostic use.

Device Class : 1

Duns Number: 784143778

Premarket Exempt : Yes

Product Code : JLS

Prescription Use : Yes

Device Count : 1

Serum Testosterone ELISA - B24211TESHUE010 Catalog Number : 11-TESHU-E01

Device Description : Intended for the direct quantitative determination of Testosterone by an enzyme Intended for the direct quantitative determination of Testosterone by an enzyme immunoassay in human serum. For in vitro diagnostic use.

Device Class : 1

Duns Number: 784143778

Premarket Exempt : No

Product Code : CDZ

Prescription Use : Yes

Device Count : 1

17-alpha Hydroxy Progesterone ELISA - B2422017OHUE010 Catalog Number : 20-17OHU-E01

Device Description : The 17-α-OH Progesterone ELISA is an enzyme immunoassay for the quantitative in The 17-α-OH Progesterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-α-OH Progesterone (17-α-OHP) in serum or plasma (EDTA, heparin, or citrate). For in vitro diagnostic use.

Device Class : 1

Duns Number: 784143778

Premarket Exempt : Yes

Product Code : JLX

Prescription Use : Yes

Device Count : 1

17-alpha Hydroxy Progesterone ELISA (Saliva) - B2422017OHUE01SLV0 Catalog Number : 20-17OHU-E01-SLV

Device Description : An enzyme immunoassay for the quantitative in vitro diagnostic measurement of ac An enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free 17-hydroxyprogesterone in saliva. Measurements of 17-hydroxyprogesterone are used as an aid in the diagnosis of various disorders of the adrenal glands or the ovaries, and as an aid in the diagnosis of late onset of 21-hydroxylase deficiency, a common cause of Congenital Adrenal Hyperplasia. This test is not intended for newborn screening.

Device Class : 1

Duns Number: 784143778

Premarket Exempt : No

Product Code : JLX

Prescription Use : Yes

Device Count : 1

Bordetella pertussis IgG ELISA - B24220BPGHUE010 Catalog Number : 20-BPGHU-E01

Device Description : The Bordetella pertussis / toxin IgG Enzyme Immunoassay Kit provides materials f The Bordetella pertussis / toxin IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Bordetella pertussis and Bordetella pertussis toxin in serum. This assay is intended for in vitro diagnostic use.

Device Class : 1

Duns Number: 784143778

Premarket Exempt : Yes

Product Code : GOX

Prescription Use : Yes

Device Count : 1

Dehydroepiandrosterone (DHEA) ELISA - B24220DHEHUE010 Catalog Number : 20-DHEHU-E01

Device Description : The DHEA ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic The DHEA ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of dehydroepiandrosterone (DHEA) in human serum and citrate plasma. For in vitro diagnostic use.

Device Class : 1

Duns Number: 784143778

Premarket Exempt : Yes

Product Code : JKC

Prescription Use : Yes

Device Count : 1

DHEA-S ELISA - B24220DHSHUE010 Catalog Number : 20-DHSHU-E01

Device Description : The DHEA-S ELISA is an enzyme immunoassay for the quantitative in vitro diagnost The DHEA-S ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of DHEA-S in serum and plasma.

Device Class : 1

Duns Number: 784143778

Premarket Exempt : Yes

Product Code : JKC

Prescription Use : Yes

Device Count : 1

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