Panocell-10, Ficin-Treated 0002385

GUDID 10888234000310

This product is used in the identification of unexpected red cell blood group antibodies. Panocell-10, Ficin-Treated is a 12-vial set of 10 vials of r

IMMUCOR, INC.

Antibody identification panel reagent red blood cell IVD, kit, agglutination
Primary Device ID10888234000310
NIH Device Record Keya8970295-709f-41e2-92ff-9089c364c7c9
Commercial Distribution StatusIn Commercial Distribution
Brand NamePanocell-10, Ficin-Treated
Version Model Number0002385
Catalog Number0002385
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
GS110888234000310 [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 Date2016-06-04

Devices Manufactured by IMMUCOR, INC.

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10888234001553 - Capture-R Select2022-09-12 The Capture-R Select Solid Phase System provides modified microwells for the immobilization of human erythrocytes for use in sol
10888234001560 - Capture-P2022-09-12 Capture-P Solid Phase System is intended for use in the detection of antibodies to platelets. Capture-P Solid Phase System is de
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10888234002291 - Capture LISS2022-09-12 Capture LISS is a low ionic solution containing glycine and the dye Bromocresol Purple and the preservative sodium azide (0.1%).
10888234002307 - Capture-R Ready Indicator Red Cells2022-09-12 Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select Solid Phase Assays
10888234002314 - Capture-P Indicator Red Cells2022-09-12 Anti-IgG coated Indicator Red Cells are intended for use in Capture-P and Capture-P Ready-Screen solid phase assays for the dete
10888234001522 - Referencells2022-08-11 Referencells (Pooled Cells) are intended for use in tube and microplate ABO serum grouping tests.

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