Anti-Cw (Monoclonal) Gamma-clone 0004819

GUDID 10888234002376

Anti-Cw (Monoclonal) Gamma-clone Blood Grouping Reagent is intended for the detection of the Cw (RH8) antigen on red blood cells by direct agglutination tube test. This product configuration is a single vial.

IMMUCOR, INC.

Anti-C^w red blood cell grouping IVD, antibody
Primary Device ID10888234002376
NIH Device Record Key06dfe6ab-21a1-4140-b8e6-5cb4590a8938
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti-Cw (Monoclonal) Gamma-clone
Version Model Number0004819
Catalog Number0004819
Company DUNS061446282
Company NameIMMUCOR, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
GS110888234002376 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-14
Device Publish Date2019-05-06

Devices Manufactured by IMMUCOR, INC.

10888234001546 - Capture-R Positive Control Serum (Weak), Capture-R Negative Control Serum2022-09-12 Immucor’s Capture-R Positive Control Serum (Weak) and Capture-R Negative Control Serum are run controls to be used in Capture-
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
10888234001577 - Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum2022-09-12 Immucor’s Capture-P Positive Control Serum (Weak) and Capture-P Negative Control Serum are run controls to be used in the Capt
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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