AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

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

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Device Description : The ALPCO Calprotectin Chemiluminescence ELISA is an in vitro diagnostic chemilu The ALPCO Calprotectin Chemiluminescence ELISA is an in vitro diagnostic chemiluminescent assay intended for the quantitative measurement of fecal calprotectin, a neutrophilic protein that is a marker of intestinal mucosal inflammation, in human stool. The ALPCO Calprotectin Chemiluminescence ELISA is intended for in vitro diagnostic use as an aid in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC), and as an aid in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other clinical and laboratory findings.

Device Class : 2

Duns Number: 784143778

Premarket Exempt : No

Product Code : NXO

Prescription Use : Yes

Device Count : 1

Device Description : The ALPCO Calprotectin Chemiluminescence ELISA is an in vitro diagnostic chemilu The ALPCO Calprotectin Chemiluminescence ELISA is an in vitro diagnostic chemiluminescent assay intended for the quantitative measurement of fecal calprotectin, a neutrophilic protein that is a marker of intestinal mucosal inflammation, in human stool. The ALPCO Calprotectin Chemiluminescence ELISA is intended for in vitro diagnostic use as an aid in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC), and as an aid in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other clinical and laboratory findings.

Device Class : 2

Duns Number: 784143778

Premarket Exempt : No

Product Code : NXO

Prescription Use : Yes

Device Count : 1

Device Description : The ALPCO STELLUX™ C-peptide Chemiluminescence ELISA is designed for the quantit The ALPCO STELLUX™ C-peptide Chemiluminescence ELISA is designed for the quantitative determination of C-peptide in human serum, heparin plasma, EDTA plasma, and tissue culture supernatants. For In Vitro Diagnostic Use.

Device Class : 1

Duns Number: 784143778

Premarket Exempt : Yes

Product Code : JKD

Prescription Use : Yes

Device Count : 1

Device Description : The ALPCO STELLUX® C-peptide Chemiluminescence ELISA is designed for the quantit The ALPCO STELLUX® C-peptide Chemiluminescence ELISA is designed for the quantitative determination of C-peptide in human serum, heparin plasma, EDTA plasma, and tissue culture supernatants. For In Vitro Diagnostic Use.

Device Class : 1

Duns Number: 784143778

Premarket Exempt : Yes

Product Code : JKD

Prescription Use : Yes

Device Count : 1

- Catalog Number : 80-CPTHU-E01.1

Device Description : The ALPCO C-peptide ELISA is designed for the quantitative determination of C-pe The ALPCO C-peptide ELISA is designed for the quantitative determination of C-peptide in human serum and plasma. For in vitro diagnostic use.

Device Class : 1

Duns Number: 784143778

Premarket Exempt : Yes

Product Code : JKD

Prescription Use : Yes

Device Count : 1

- Catalog Number : 80-CPTHU-E10

Device Description : The ALPCO C-peptide ELISA Jumbo is designed for the quantitative determination o The ALPCO C-peptide ELISA Jumbo is designed for the quantitative determination of C-peptide in human serum and plasma. For in vitro diagnostic use.

Device Class : 1

Duns Number: 784143778

Premarket Exempt : Yes

Product Code : JKD

Prescription Use : Yes

Device Count : 1

Device Description : The ALPCO Insulin Chemiluminescence ELISA is designed for the quantitative deter The ALPCO Insulin Chemiluminescence ELISA is designed for the quantitative determination of insulin in human serum, heparin plasma, and tissue culture supernatants. For in vitro diagnostic use.

Device Class : 1

Duns Number: 784143778

Premarket Exempt : Yes

Product Code : CFP

Prescription Use : Yes

Device Count : 1

Device Description : The ALPCO Insulin Chemiluminescence ELISA Jumbo is designed for the quantitative The ALPCO Insulin Chemiluminescence ELISA Jumbo is designed for the quantitative determination of insulin in human serum, heparin plasma, and tissue culture supernatants. For in vitro diagnostic use.

Device Class : 1

Duns Number: 784143778

Premarket Exempt : Yes

Product Code : CFP

Prescription Use : Yes

Device Count : 1

- Catalog Number : 80-INSHU-E01.1

Device Description : The ALPCO Insulin ELISA is designed for the quantitative determination of insuli The ALPCO Insulin ELISA is designed for the quantitative determination of insulin in serum and plasma. For in vitro diagnostic use.

Device Class : 1

Duns Number: 784143778

Premarket Exempt : Yes

Product Code : CFP

Prescription Use : Yes

Device Count : 1

- Catalog Number : 80-INSHU-E10.1

Device Description : The ALPCO Insulin ELISA is designed for the quantitative determination of insuli The ALPCO Insulin ELISA is designed for the quantitative determination of insulin in serum and plasma. For in vitro diagnostic use.

Device Class : 1

Duns Number: 784143778

Premarket Exempt : Yes

Product Code : CFP

Prescription Use : Yes

Device Count : 1