FDA.reportPublic FDA data

W.A.R.M.

Primary DI
10888234001010
Brand
W.A.R.M.
Company
IMMUCOR, INC.
Model
0057319
Catalog number
0057319
Device description
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 serological complexities. W.A.R.M. is a specially formulated preparation of dithiothreitol and cysteine-activated papain in a phosphate buffer. It has been filtered and lyophilized. This product must be reconstituted with deionized water and mixed thoroughly prior to use. The product configuration is ten (10) vials.
Published
2016-04-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KSKSolution, Stabilized Enzyme

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSKSolution, Stabilized EnzymeHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK8300080

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK8300080

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888234001010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088823400101010888234001010

GMDN Terms#

Term, Definition table
TermDefinition
Papain immunohaematology reagent IVDA substance or reactant that is a papain enzyme solution intended to be used in immunohaematological testing of a clinical specimen to enhance or potentiate red cell agglutination reactions by enzymatically digesting red cell membrane proteins and removing sialic acid residues.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius10 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-466-8267tech_support@immucor.com

Regulatory Flags#

DUNS number
061446282
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888234002291Capture LISS006690800669082022-09-03
10888234001027H.P.C. (Human Platelet Concentrate)005732000573202016-04-18
10888234002475ImmuLINK00303112024-12-05
10888234000495Red Blood Cell (RBC) Storage Solution000503600050362016-04-15
10888234001065Specimen Diluent006605200660522016-04-18
10888234001072Specimen Diluent006605300660532016-04-18
10888234001041Galileo Neo006459900645992016-04-18
10888234001584Galileo Echo008700000870002016-04-18
10888234001591CMT Plates008900000890002016-04-18
10888234002321NEO Iris006459700645972018-12-10
10888234002338Echo Lumena008699800869982018-06-01
10888234001546Capture-R Positive Control Serum (Weak), Capture-R Negative Control Serum006690200669022022-09-03
10888234001553Capture-R Select006690300669032022-09-03
10888234001560Capture-P006690400669042022-09-03
10888234001577Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum006690500669052022-09-03
10888234002307Capture-R Ready Indicator Red Cells006690700669072022-09-03
10888234002314Capture-P Indicator Red Cells006690600669062022-09-03
10888234001522Referencells006690000669002022-08-03
10888234001539Capture-R Ready-Screen 3006690100669012022-08-01
10888234002239Gamma-Clone Anti-Fya (Monoclonal) Blood Grouping Reagent10 mL size vial / 5mL fill volume00664302022-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
23661562105452PapainDIAGASTKSK2018-05-01
07611969952199IH-PapainBio-Rad Medical Diagnostics GmbHKSK2018-04-05
10758750030330ORTHOTM Sera Papain ALBA BIOSCIENCE LIMITEDKSK2017-08-30
05060242471223ALBAzyme™ Papain Solution KitALBA BIOSCIENCE LIMITEDKSK2017-03-29
10888234000891Gamma-QuinIMMUCOR, INC.KSK2016-04-19
10888234000709GammaZyme-FIMMUCOR, INC.KSK2016-04-15
10888234000716GammaZyme-BIMMUCOR, INC.KSK2016-04-15
10888234000990Freeze Dried PapainIMMUCOR, INC.KSK2016-04-15
23661562173307Beckman Coulter® PK® Systems BromelinDIAGASTKSK2015-09-18
05060242471544ALBAhance LISS Additive ReagentALBA BIOSCIENCE LIMITEDKSK2014-11-14