ESR-10 Manual Rack 240321

GUDID 00844509002123

A 10-position manual Modified Westergren system used for determining the erythrocyte sedimentation rate (ESR) of whole blood in 30 minutes using 1.2ml Streck ESR-Vacuum Tubes.

STRECK, INC.

Erythrocyte sedimentation rate (ESR) rack IVD, scaled measure
Primary Device ID00844509002123
NIH Device Record Key8875c98a-9037-489d-b3d2-91b2a08459ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameESR-10 Manual Rack
Version Model Number240321
Catalog Number240321
Company DUNS072915986
Company NameSTRECK, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-228-6090
Emailcustserv@streck.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100844509002123 [Primary]

FDA Product Code

GKBDevice, Automated Sedimentation Rate

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-19

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