American Laboratory Products Company

Matched from indexed company URL: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1222302	1000121039	American Laboratory Products Company	1	Y	2026-01-01	26 Keewaydin Drive Unit G Salem NH US 03079

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
B24224MABHUE010	Microalbumin ELISA - The Microalbumin assay procedure is a competitive ELISA in which enzyme labeled albumin competes with albumin insamples for limited antibody binding sites on the microplate. After incubation for a fixed time, separation of bound fromfree is achieved by simple decantation and plate washing. The enzyme activity on the plate is measured using an enzymesubstrate and a chromogen. The absorbency of the color developed is read in an ELISA colorimetric reader. The measuredabsorbance is inversely proportional to the concentration of bound albumin in the microplate. The concentration ofalbumin in the urine is determined from a calibration curve.	800.592.5726	CS@alpco.com
B24230PANHUE010	Pancreatic Elastase ELISA - The Pancreatic Elastase ELISA is intended for the quantitative determination of pancreatic elastase in human stool samples. For In Vitro Diagnostic Use.	800.592.5726	cs@alpco.com

alpco.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
76175	1549028855	K992799	SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT	GGT	2000-06-07
76175	1396363172	K992528	BIOCHECK IGE ELISA, MODEL BC-1035	DGC	1999-09-21
76175	1480985237	K992517	BIOCHECK FERRITIN ELISA MODEL BC-1025	DBF	1999-09-24
76175	1811902725	K991741	BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027	JHI	1999-07-22
76175	1539324603	K991432	BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007	KLI	1999-06-02
76175	1989450383	K991146	TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001	JLW	1999-06-22
76175	1924090810	K990993	BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003	JLW	1999-06-22
76175	2004112730	K982608	SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT	CKG	1998-08-19
76175	1514655647	K982491	SANGUI BIOTECH, INC. CALCITONIN ELISA KIT	JKR	1998-09-03
76175	1274000825	K974306	SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA	CEW	1997-12-23
76175	1991559263	K971779	TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA	CDP	1997-06-16
76175	1693128054	K954256	ANTI-TPO	JNL	1995-11-27
76175	1165309775	K220763	ALPCO Calprotectin Immunoturbidimetric Assay	NXO	2023-04-13
76175	1939632901	K191807	ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device	NXO	2019-10-25
76175	1524066153	K123364	25OH VITAMIN D TOTAL ELISA TEST	MRG	2013-07-15
76175	1197429978	K062534	ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE	JLX	2008-01-29
76175	1969250796	K062217	AESKULSKA BETA2-GLYCO-A	MSV	2006-12-13
76175	1531555637	K051806	CARE FECAL OCCULT BLOOD TEST, MODEL KT313	KHE	2005-10-03
76175	1784003800	K042644	AESKULISA TTG A AND AESKULISA TTG G	MVM	2005-06-01
76175	1119260799	K041817	WEST NILE DETECT IGM ELISA	NOP	2004-11-19
76175	2036066100	K041628	AESKULISA DS DNA G	LSW	2004-10-14
76175	1255750926	K040463	AESKULISA CARDIOLIPIN AGM	MID	2004-05-12
76175	1140292320	K032469	AESKULISA ANA 8PRO	LLL	2003-12-16
76175	1599876151	K030730	FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT	CDZ	2003-08-18
76175	1119877602	K014120	TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA)	CDZ	2002-02-08
76175	1534990042	K013062	BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT	MMI	2002-01-08
76175	1473040277	K001022	BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061	JZG	2000-09-26
76175	1074854973	DEN100020	DENV DETECT IGM CAPTURE ELISA	OSU	2011-04-08
76175	1142899733
76175	1412990091
76175	1854713168
76175	1897864070
76175	1929915235
76175	1000748880
76175	1021664610
76175	1103622089
76175	1222866080
76175	1275551228
76175	1327510936
76175	1337487360
76175	1359855327
76175	1526290078
76175	1560901012
76175	1563478313
76175	1602335919
76175	1694811644
76175	1714487511
76175	1745894051
76175	1774511397
76175	1811591938
76175	1832931302
76175	1901454988
76175	1938735863
76175	1969872280
76175	2014269529

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
NXO	2	2023-04-13
CDZ	2	2003-08-18
JLW	2	1999-06-22
KLI	2	1999-06-02
MRG	1	2013-07-15
OSU	1	2011-04-08
JLX	1	2008-01-29
MSV	1	2006-12-13
KHE	1	2005-10-03
MVM	1	2005-06-01
NOP	1	2004-11-19
LSW	1	2004-10-14
MID	1	2004-05-12
LLL	1	2003-12-16
MMI	1	2002-01-08
JZG	1	2000-09-26
GGT	1	2000-06-07
DBF	1	1999-09-24
DGC	1	1999-09-21
JHI	1	1999-07-22
JKR	1	1998-09-03
CKG	1	1998-08-19
CEW	1	1997-12-23
CDP	1	1997-06-16
JNL	1	1995-11-27

GUDID#

ALPCO Lactoferrin CLIA Kit - The Lactoferrin CLIA Kit is a chemiluminescent immunoassay based on the use of specific antibodies against lactoferrin. The KleeYa system allows for complete automation of immunoassays. The Lactoferrin CLIA Kit is intended for use by trained laboratory personnel for the quantitative measurement of fecal lactoferrin in human stool samples.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2026-03-31
Pancreatic Elastase ELISA - The Pancreatic Elastase ELISA is intended for the quantitative determination of pancreatic elastase in human stool samples. For In Vitro Diagnostic Use.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2020-07-17
Unfilled Easy 2 Stool Extraction Device - The unfilled Easy 2 Stool Extraction Device is intended for the preparation of human stool samples in conjunction with a designated buffer for analysis in compatible test kits. It is for in vitro diagnostic use in the United States and Canada.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2026-02-02
Easy 2 Stool Extraction Device - The Easy 2 Stool Extraction Device is a universal tool for the preparation of stool extractions for analysis in compatible ALPCO test kits. For In Vitro Diagnostic Use.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2025-10-30
ALPCO Calprotectin Chemiluminescence ELISA - 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.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2019-11-04
Microalbumin ELISA - The Microalbumin assay procedure is a competitive ELISA in which enzyme labeled albumin competes with albumin insamples for limited antibody binding sites on the microplate. After incubation for a fixed time, separation of bound fromfree is achieved by simple decantation and plate washing. The enzyme activity on the plate is measured using an enzymesubstrate and a chromogen. The absorbency of the color developed is read in an ELISA colorimetric reader. The measuredabsorbance is inversely proportional to the concentration of bound albumin in the microplate. The concentration ofalbumin in the urine is determined from a calibration curve.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2018-01-16
Lactoferrin CLIA Re-Calibrator and Control Set - The Lactoferrin CLIA Re-Calibrator and Control Set is an accessory used in conjunction with the Lactoferrin CLIA Kit (80-LACHU-FC100, 80-LACHU-FC900) by trained laboratory personnel. For In Vitro Diagnostic Use in the United States.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2025-06-06
Pancreatic Elastase CLIA Re-Calibrator and Control Set - The Pancreatic Elastase CLIA Re-Calibrator and Control Set is an accessory used in conjunction with the Pancreatic Elastase CLIA kit (80-PANHU-FC100 or 80-PANHU-FC900) by trained laboratory personnel. For in vitro diagnostic use in the United States.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2025-06-06
Total Thyroxine ELISA (Total T4 ELISA) - The Total Thyroxine ELISA (Total T4 ELISA) is intended for use in the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2017-08-03
Pregnenolone ELISA - Intended for the direct quantitative determination of Pregnenolone by enzyme immunoassay using human serum. For in vitro diagnostic use.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2020-09-25
Pancreatic Elastase Chemiluminescence ELISA - 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.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2022-09-09
ALPCO Lactoferrin CLIA Kit - The Lactoferrin CLIA Kit is a chemiluminescent immunoassay based on the use of specific antibodies against lactoferrin. The KleeYa system allows for complete automation of immunoassays. The Lactoferrin CLIA Kit is intended for use by trained laboratory personnel for the quantitative measurement of fecal lactoferrin in human stool samples.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2025-03-03
Human Growth Hormone ELISA - The Glucagon ELISA is for the quantitative measurement of Growth Hormone (GH) in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diagnostic use.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2025-01-20
ALPCO Pancreatic Elastase CLIA - The Pancreatic Elastase CLIA kit is a chemiluminescent immunoassay (CLIA) intended for use by trained laboratory personnel for the quantitative measurement of fecal pancreatic elastase (PE) in human stool. The Pancreatic Elastase CLIA kit is intended for in vitro diagnostic use as an aid in the diagnosis and treatment of pancreatic disease, including exocrine pancreatic insufficiency (EPI), in conjunction with other clinical and laboratory findings. The test is specifically designed for use with the KleeYa platform. For In Vitro Diagnostic Use in the United States.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2024-07-25
Pancreatic Elastase Chemiluminescence ELISA - 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.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2022-09-09
Glucagon ELISA - The Glucagon ELISA is a quantitative Enzyme-Linked Immunosorbent Assay for the determination of Glucagon in human EDTA plasma samples.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2024-10-23
Total Triiodothyronine (Total T3) ELISA - The Total Triiodothyronine (Total T3) ELISA Kit is intended for the quantitative determination of total triiodothyronine (T3) concentration in human serum and plasma.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2024-07-22
ALPCO Calprotectin Immunoturbidimetric Assay - The ALPCO Calprotectin Immunoturbidimetric Assay is an in-vitro diagnostic assay intended for the quantitative measurement of human fecal calprotectin in human stool. The ALPCO Calprotectin Immunoturbidimetric Assay is intended for in-vitro diagnostic use as an aid in 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.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2023-08-18
Calprotectin Immunoturbidimetric Assay - Calibrators - The Calprotectin Immunoturbidimetric Assay - Calibrators is an accessory used in conjunction with the Calprotectin Immunoturbidimetric Assay (80-CALPHU-IT200) by trained laboratory personnel.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2023-08-18
ALPCO Calprotectin Immunoturbidimetric Assay - The Calprotectin Immunoturbidimetric Assay - Controls is an accessory used in conjunction with the Calprotectin Immunoturbidimetric Assay (80-CALPHU-IT200) by trained laboratory personnel.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2023-08-18
ALPCO Calprotectin Immunoturbidimetric Assay - The ALPCO Calprotectin Immunoturbidimetric Assay is an in-vitro diagnostic assay intended for the quantitative measurement of human fecal calprotectin in human stool. The ALPCO Calprotectin Immunoturbidimetric Assay is intended for in-vitro diagnostic use as an aid in 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.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2023-06-09
Ultrasensitive Estradiol ELISA - The Estradiol Ultrasensitive ELISA is an enzyme immunoassay for the quantitative measurement of Estradiol in serum and plasma. For In Vitro Diagnostic Use.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2020-09-25
Human Chorionic Gonadotropin ELISA - The Human Chorionic Gonadotropin ELISA is intended for use in the quantitative determination of human chorionic gonadotropin (hCG) concentration in human serum. The assay is for use in the early diagnosis of pregnancy in a clinical laboratory setting.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2017-08-03
Ultrasensitive Estradiol ELISA - The Ultrasensitive Estradiol ELISA is an enzyme immunoassay for the quantitative measurement of estradiol in serum or plasma (EDTA, heparin, or citrate plasma). For In Vitro Diagnostic Use.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2023-06-07
Pregnenolone ELISA - Intended for the direct quantitative determination of Pregnenolone by enzyme immunoassay using human serum. For in vitro diagnostic use.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2023-05-25
Free Testosterone ELISA - For the direct quantitative determination of Free Testosterone by an enzyme immunoassay in human serum. For in vitro diagnostic use.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2020-06-02
Serum Testosterone ELISA - Intended for the direct quantitative determination of Testosterone by an enzyme immunoassay in human serum. For in vitro diagnostic use.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2020-09-25
Prolactin ELISA - The Prolactin ELISA is an enzyme immunoassay for the quantitative determination of Prolactin in human serum. For in vitro diagnostic use in the United States of America. For research use only in other territories.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2023-02-22
Extraction Buffer 4X, 225mL Fill - General purpose reagent used in preparation of samples for ALPCO stool-based biomarker kits.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2022-10-11
Extraction Buffer 4X, 55mL Fill - General purpose reagent used in preparation of samples for ALPCO stool-based biomarker kits.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2022-10-11
Beta-2 Microglobulin ELISA - The Beta-2 Microglobulin ELISA is intended for use in the quantitative determination of beta-2-microglobulin in human serum.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2017-08-03
Glucagon RIA - The Glucagon RIA is a radioimmunoassay for the quantitative measurement of glucagon in human plasma.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2020-06-02
ALPCO C-peptide ELISA - The ALPCO C-peptide ELISA is designed for the quantitative determination of C-peptide in human serum and plasma. For in vitro diagnostic use.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2020-07-17
Ferritin ELISA - This Ferritin ELISA is intended for use in the quantitative determination of ferritin in human serum. The assay is to be used in the diagnosis of diseases affecting iron metabolism.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2017-08-03
Total IgE ELISA - The Total IgE ELISA is intended for use in the quantitative determination of immunoglobulin E in human serum. The assay is to be used for the assessment of hypersensitive and allergic reactions in patients.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2017-08-03
Total Triiodothyronine T3 ELISA (Total T3 ELISA) - The Total Triiodothyronine T3 ELISA (Total T3 ELISA) is intended for use in the quantitative determination of triiodothyronine (T3) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2017-08-03
Thyroid Stimulating Hormone (TSH) ELISA - The Thyroid Stimulating Hormone (TSH) ELISA is intended for use in the quantitative determination of thyroid stimulating hormone (TSH) concentration in human serum. The assay is useful in the diagnosis of thyroid or pituitary disorders.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2017-08-03
Thyroid Stimulating Hormone (TSH) Ultrasensitive ELISA - The Thyroid Stimulating Hormone (TSH) Ultrasensitive ELISA is intended for use in the quantitative determination of thyroid stimulating hormone (TSH) concentration in human serum. The assay is useful in the diagnosis of thyroid or pituitary disorders.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2017-08-03
ANA-8Pro ELISA - The ANA-8Pro ELISA is a solid phase enzyme immunoassay for the separate qualitative detection of IgG antibodies against eight cellular and nuclear antigens in human serum. The wells are separately coated with recombinant 70 kDa U1 snRNP, SS-B, SS-A 52 kDa, Scl 70, centromere protein B (CenpB), Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is an aid in the differential diagnosis of systemic rheumatic diseases and should be used in conjunction with other serological tests and clinical findings.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2017-08-28
Anti-Beta 2 Glycoprotein Screen ELISA - Anti-Beta 2 Glycoprotein Screen ELISA is a solid phase enzyme immunoassay employing native Beta-2glycoprotein I highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against Beta-2-glycoprotein I in human serum.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
2017-08-28

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