FDA.reportPublic FDA data

Human Chorionic Gonadotropin (hCG) ELISA

Primary DI
00840239017833
Brand
Human Chorionic Gonadotropin (hCG) ELISA
Company
DRG International Inc
Model
EIA-1783
Catalog number
EIA-1783
Device description
The hCG ELISA is intended for 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
2019-03-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00840239017833PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239017833008402390178338402390178330840239017833

GMDN Terms#

Term, Definition table
TermDefinition
Human chorionic gonadotropin beta-core fragment (beta-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 beta-core fragment human chorionic gonadotropin (beta-HCG) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Total Volume1Milliliter
Total Volume11Milliliter
Total Volume13Milliliter
Total Volume18Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(973)564-7555corp@drg-international.com

Regulatory Flags#

DUNS number
075150847
Device count
1
No natural rubber latex
true

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