Pulse Scientific Inc.

GUDID 00628055726036

Pulse Scientific Inc

Rheumatoid factor IVD, kit, agglutination
Primary Device ID00628055726036
NIH Device Record Key9c1a333d-b5a9-40e1-93c0-cb2c95bab78e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePulse Scientific Inc.
Version Model Number10503
Company DUNS249257254
Company NamePulse Scientific Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
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
GS100628055726036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DHRSystem, Test, Rheumatoid Factor

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 Date2016-11-04

On-Brand Devices [Pulse Scientific Inc.]

0062805572603610503
0062805572602910103
0062805572601210605
0062805572600510603

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