Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1222302

FEI Number

1000121039

Entity Name

American Laboratory Products Company

City/State/Country

Salem, NH, US

Establishment Address

26 Keewaydin Drive, Unit G, Salem, NH 03079, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AMERICAN LABORATORY PRODUCTS CO., LTD. (Owner Number: 9000664)

Owner / Operator Contact Address

26 KEEWAYDIN DR., BLDG- G, Salem, NH 03079, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

25OH Vitamin D Total ELISA Total 25-OH Vitamin D ELISA Human Chorionic Gonadotropin ELISA (hCG ELISA) Human Chroionic Gonad. EIA Calcitonin ELISA ACTH EIA Adrenocorticotropic Hormone ELISA (ACTH ELISA) Easy Stool Extraction Device Easy 2 Stool Extraction Device Unfilled Easy 2 Stool Extraction Devices Pregnenolone EIA Pregnenolone ELISA Luteinizing Hormone EIA LH (Luteinizing Hormone) (Urine) ELISA Luteinizing Hormone ELISA (LH ELISA) Sample Extraction Buffer Anti-ds-DNA-G ELISA Free Testosterone ELISA Progesterone EIA Progesterone ELISA Intact PTH ELISA (1-84) Anti-Beta 2 Glycoprotein Screen ELISA ALPCO Calprotectin Turbidimetric Assay Androstenedione ELISA Androstenedione EIA Total Estrogens ELISA Estradiol EIA Ultrasensitive Estradiol ELISA Estradiol ELISA Estradiol Ultrasensitive EIA Serum Testosterone ELISA Total Testosterone ELISA Human Growth Hormone ELISA (HGH ELISA) Human Growth Hormone EIA Human Growth Hormone ELISA (HGH) ELISA Follicle Stimulating Hormone ELISA (FSH ELISA) Follicle Stimulating Hormone EIA Echinococcus granulosus (IgG) ELISA Echinococcus Granulosus IgG ELISA Anti-Tissue Transglutaminase-A ELISA Anti Tissue Transglutaminase-G ELISA (Anti-tTg-G ELISA) Anti-tTg-A ELISA 17-?-OH Progesterone ELISA 17-alpha Hydroxy Progesterone ELISA Total Thyroxine ELISA (Total T4 ELISA) Erythropoietin ELISA (EPO ELISA) Anti-Cardiolipin-A ELISA Glucagon RIA Glucagon ELISA Total IgE ELISA IgE EIA Free Estriol (E3) EIA Free Estriol (E3) ELISA Free Estriol EIA Estriol EIA Free Estriol ELISA Estriol ELISA C-peptide ELISA STELLUX Intact Proinsulin Chemiluminescence ELISA STELLUX C-peptide Chemiluminescence ELISA C-peptide ELISA, Jumbo Pack STELLUX Proinsulin (Intact) Chemiluminescence ELISA Proinsulin (Intact) Chemiluminescence ELISA Intact Proinsulin Chemiluminescence ELISA C-peptide Chemiluminescence ELISA Lab Pack STELLUX Proinsulin (Total) Chemiluminescence ELISA STELLUX C-peptide Chemiluminescence ELISA Lab Pack

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2015-04-30
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2011-12-20
JKR	Radioimmunoassay, Calcitonin	Clinical Chemistry	Class 2	862.1140	2011-12-20
CKG	Radioimmunoassay, Acth	Clinical Chemistry	Class 2	862.1025	2011-12-20
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2012-08-28
JNG	Radioimmunoassay, Pregnenolone	Clinical Chemistry	Class 1	862.1615	2011-12-20
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2011-12-20
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2022-02-17
LSW	Anti-Dna Antibody, Antigen And Control	Immunology	Class 2	866.5100	2017-01-13
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2011-12-20
JLS	Radioimmunoassay, Progesterone	Clinical Chemistry	Class 1	862.1620	2011-12-20
CEW	Radioimmunoassay, Parathyroid Hormone	Clinical Chemistry	Class 2	862.1545	2011-12-20
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2017-08-24
NXO	Calprotectin, Fecal	Immunology	Class 2	866.5180	2023-05-25
CIZ	Radioimmunoassay, Androstenedione	Clinical Chemistry	Class 1	862.1075	2011-12-20
JMD	Radioimmunoassay, Total Estrogens, Nonpregnancy	Clinical Chemistry	Class 1	862.1275	2018-09-20
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	Class 1	862.1260	2011-12-20
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2011-12-20
CFL	Radioimmunoassay, Human Growth Hormone	Clinical Chemistry	Class 1	862.1370	2011-12-20
CGJ	Radioimmunoassay, Follicle-Stimulating Hormone	Clinical Chemistry	Class 1	862.1300	2011-12-20
GPF	Antigen, Agglutinating, Echinococcus Spp.	Microbiology	Class 1	866.3200	2011-12-20
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	Class 2	866.5660	2017-01-13
JLX	Radioimmunoassay, 17-Hydroxyprogesterone	Clinical Chemistry	Class 1	862.1395	2020-06-02
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2011-12-20
GGT	Assay, Erythropoietin	Hematology	Class 2	864.7250	2011-12-20
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2017-08-24
JME	Radioimmunoassay, Glucagon	Clinical Chemistry	Class 1	862.1335	2018-08-07
DGC	Ige, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2011-12-20
CGI	Radioimmunoassay, Estriol	Clinical Chemistry	Class 1	862.1265	2011-12-20
JKD	Radioimmunoassay, C-Peptides Of Proinsulin	Clinical Chemistry	Class 1	862.1135	2007-12-04

Official Correspondent

James Richard

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AMERICAN LABORATORY PRODUCTS CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K200509	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Vitamin D Total (VitD)	2020-05-29
K964536	Teco Diagnostics	ONE-STEP DIPSTICK PREGNANCY TEST	1997-02-11
K904016	Bhc Biotech , Ltd.	MAXI TEST	1990-10-15
K870259	Leeco Diagnostics, Inc.	VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044	1987-03-10
K820822	Hybritech, Inc.	TANDEM HCG KIT	1982-04-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-05	Abbott Health Products, Inc.	2	AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
Z-0034-2008	Louisville Apl Diagnostics Inc	2	APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in Seabrook, TX 77856).

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2020726	MONOBIND, INC.	Lake Forest, CA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1222302. Last updated year: 2026. Please use registration number 1222302 when referencing this establishment in official correspondence.