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

P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin (JNN) (2) Radioimmunoassay, Immunoreactive Insulin (CFP) (2) Radioimmunoassay, C-Peptides Of Proinsulin (JKD) (1)

Premarket Exempt

No Yes

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ALPCO Ultrasensitive Insulin ELISA - B24280INSHUUE010 Catalog Number : 80-INSHUU-E01.1

Device Description : The ALPCO Ultrasensitive Insulin ELISA is designed for the quantitative determin The ALPCO Ultrasensitive Insulin ELISA is designed for the quantitative determination of insulin in human 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

ALPCO Ultrasensitive Insulin ELISA Jumbo - B24280INSHUUE100 Catalog Number : 80-INSHUU-E10

Device Description : The ALPCO Ultrasensitive Insulin ELISA Jumbo is designed for the quantitative de The ALPCO Ultrasensitive Insulin ELISA Jumbo is designed for the quantitative determination of insulin in human 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

Pancreatic Elastase Chemiluminescence ELISA - B24280PANHUCH010 Catalog Number : 80-PANHU-CH01

Device Description : The Pancreatic Elastase Chemiluminescence ELISA is a quantitative assay for the The Pancreatic Elastase Chemiluminescence ELISA is a quantitative assay for the determination of pancreatic elastase (PE) in human stool. This assay detects both the CELA3A and CELA3B isoforms of pancreatic elastase.

Device Class : 1

Duns Number: 784143778

Premarket Exempt : Yes

Product Code : JNN

Prescription Use : Yes

Device Count : 1

Pancreatic Elastase Chemiluminescence ELISA - B24280PANHUCH500 Catalog Number : 80-PANHU-CH50

Device Class : 1

Duns Number: 784143778

Premarket Exempt : Yes

Product Code : JNN

Prescription Use : Yes

Device Count : 1

STELLUX® Chemi Human Total Proinsulin ELISA - B24280PINHUTCH010 Catalog Number : 80-PINHUT-CH01

Device Description : The Proinsulin (Total) Chemiluminescence ELISA is designed for the quantitative The Proinsulin (Total) Chemiluminescence ELISA is designed for the quantitative determination of proinsulin in human serum, plasma (EDTA and heparin), 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

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