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

Clear

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

Device Description : The ALPCO Ultrasensitive Insulin ELISA is designed for the quantitative determin

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

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

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 Description : The Pancreatic Elastase Chemiluminescence ELISA is a quantitative assay for the

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

Device Class : 1

Duns Number: 784143778

Premarket Exempt : Yes

Product Code : JKD

Prescription Use : Yes

Device Count : 1

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