α-spot

GUDID 00860802000390

LFP Alpha-Spot Kit

EASTERN BUSINESS FORMS INC

Blood collection paper
Primary Device ID00860802000390
NIH Device Record Keyd8ff873c-715a-43f4-a14b-3326bfac911e
Commercial Distribution StatusIn Commercial Distribution
Brand Nameα-spot
Version Model NumberW201
Company DUNS079861573
Company NameEASTERN BUSINESS FORMS INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860802000390 [Primary]
GS110860802000397 [Package]
Package: [7200 Units]
In Commercial Distribution

FDA Product Code

JKATubes, Vials, Systems, Serum Separators, Blood Collection

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-16
Device Publish Date2021-08-06

On-Brand Devices [α-spot]

00860802000390LFP Alpha-Spot Kit
10850039198035LFP Alpha-Spot Kit

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.