C-Reactive Protein HS ELISA EIA-3954

GUDID 00840239039545

The C-Reactive Protein HS ELISA is intended for the quantitative determination of C-reactive protein (CRP) in human serum. Enhanced sensitivity measurements of CRP can be useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.

DRG International Inc

C-reactive protein (CRP) IVD, kit, fluorescent immunoassay

Primary Device ID	00840239039545
NIH Device Record Key	59ad9cbe-8b05-4bd9-817d-d80870eaa11d
Commercial Distribution Status	In Commercial Distribution
Brand Name	C-Reactive Protein HS ELISA
Version Model Number	EIA-3954
Catalog Number	EIA-3954
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

Device Dimensions

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Total Volume	11 Milliliter
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Total Volume	11 Milliliter
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Total Volume	11 Milliliter
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Total Volume	12 Milliliter
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Total Volume	11 Milliliter
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00840239039545 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K003851

FDA Product Code

DCK	C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL

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	2020-03-30
Device Publish Date	2019-03-20

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