ASI Staphslide Test NC-280-2CE

GUDID 00816057020119

Detection of coagulase associated with Staph. aureus, Export

ARLINGTON SCIENTIFIC, INC.

Staphylococcus aureus culture isolate antigen IVD, kit, agglutination Staphylococcus aureus culture isolate antigen IVD, kit, agglutination Staphylococcus aureus culture isolate antigen IVD, kit, agglutination
Primary Device ID00816057020119
NIH Device Record Keye131992c-3bb4-40f4-86b2-292cf9bfe416
Commercial Distribution StatusIn Commercial Distribution
Brand NameASI Staphslide Test
Version Model NumberNC-280-2CE
Catalog NumberNC-280-2CE
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
GS100816057020119 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWXKit, Screening, Staphylococcus Aureus

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 Staphslide Test]

00816057020119Detection of coagulase associated with Staph. aureus, Export
00816057020102Detection of coagulase associated with Staph. aureus
00816057020096Detection of coagulase associated with Staph. aureus, Export
00816057020089Detection of coagulase associated with Staph. aureus
00816057020072Detection of coagulase associated with Staph. aureus, Export
00816057020065Detection of coagulase associated with Staph aureus

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