ASI CRP Slide Test NC-5001000

GUDID 00816057020393

Detection of C-Reactive Protein

ARLINGTON SCIENTIFIC, INC.

C-reactive protein (CRP) IVD, kit, precipitation/immunodiffusion
Primary Device ID00816057020393
NIH Device Record Key5b7d88d2-f235-4684-982f-0837b16ba397
Commercial Distribution StatusIn Commercial Distribution
Brand NameASI CRP Slide Test
Version Model NumberNC-5001000
Catalog NumberNC-5001000
Company DUNS785966607
Company NameARLINGTON SCIENTIFIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone801-489-8911
Emailinfo@arlingtonscientific.com
Phone801-489-8911
Emailinfo@arlingtonscientific.com
Phone801-489-8911
Emailinfo@arlingtonscientific.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816057020393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DCNSystem, Test, C-Reactive Protein

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-08

On-Brand Devices [ASI CRP Slide Test]

00816057020393Detection of C-Reactive Protein
00816057020386Detection of C-Reactive Protein, Export
00816057020379Detection of C-Reactive Protein
00816057020362Detection of C-Reactive Protein, Export
00816057020355Detection of C-Reactive Protein
00816057020348Detection of C-Reactive Protein, Export
00816057020331Detection of C-Reactive Protein

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