FDA.reportPublic FDA data

Human Chorionic Gonadotropin ELISA

Primary DI
B24225HCGHUE010
Brand
Human Chorionic Gonadotropin ELISA
Company
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Model
25-HCGHU-E01
Catalog number
25-HCGHU-E01
Device description
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.
Published
2017-08-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JHIVisual, Pregnancy Hcg, Prescription Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHIVisual, Pregnancy Hcg, Prescription UseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991741000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991741000BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027Biocheck, Inc.1999-07-22JHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B24225HCGHUE010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Total human chorionic gonadotropin (HCG) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total human chorionic gonadotropin (HCG), which may include intact HCG, nicked HCG, free alpha-HCG subunits and/or free beta-HCG subunits, in a clinical specimen using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.592.5726cs@alpco.com

Regulatory Flags#

DUNS number
784143778
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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