W.A.R.M. 0057319

GUDID 10888234001010

W.A.R.M. (Warm Autoantibody Removal Medium) is used for the removal of warm-reactive autoantibody from red blood cells to facilitate resolution of ser

IMMUCOR, INC.

Papain immunohaematology reagent IVD
Primary Device ID10888234001010
NIH Device Record Key87029884-80ed-477a-a397-63ba7170f6a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameW.A.R.M.
Version Model Number0057319
Catalog Number0057319
Company DUNS061446282
Company NameIMMUCOR, 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 Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
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
GS110888234001010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSKSolution, Stabilized Enzyme

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 Date2016-04-18

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.

Trademark Results [W.A.R.M.]

Mark Image

Registration | Serial
Company
Trademark
Application Date
W.A.R.M.
W.A.R.M.
73450163 not registered Dead/Abandoned
COOPERBIOMEDICAL, INC.
1983-10-28

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