Panoscreen I, II, and III 0002377

GUDID 10888234000280

Panoscreen I, II, and III is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual tube method. The configuratio

IMMUCOR, INC.

Antibody screening reagent red blood cell IVD, kit, agglutination
Primary Device ID10888234000280
NIH Device Record Key6c4c81e3-35ef-48ab-ad7e-ed18a65d136e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePanoscreen I, II, and III
Version Model Number0002377
Catalog Number0002377
Company DUNS061446282
Company NameIMMUCOR, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-855-466-8267
Emailtech_support@immucor.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110888234000280 [Primary]

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 Date2014-09-24

On-Brand Devices [Panoscreen I, II, and III]

10888234000303Panoscreen I, II, and III is intended for use in the detection of unexpected IgG antibodies to r
10888234000280Panoscreen I, II, and III is intended for use in the detection of unexpected IgG antibodies to r

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