Human Chorionic Gonadotropin (hCG) ELISA EIA-1783

GUDID 00840239017833

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.

DRG International Inc

Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, enzyme immunoassay (EIA)

Primary Device ID	00840239017833
NIH Device Record Key	915ac122-b410-438a-8310-7020b7c065be
Commercial Distribution Status	In Commercial Distribution
Brand Name	Human Chorionic Gonadotropin (hCG) ELISA
Version Model Number	EIA-1783
Catalog Number	EIA-1783
Company DUNS	075150847
Company Name	DRG International Inc
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00840239017833 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K991741

FDA Product Code

JHI	Visual, pregnancy hCG, prescription use

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2020-04-01
Device Publish Date	2019-03-20

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