FDA.reportPublic FDA data

IH-Papain

Primary DI
07611969952199
Brand
IH-Papain
Company
Bio-Rad Medical Diagnostics GmbH
Model
813540100
Device description
IH-Papain; 1 x 5mL vial lyophilized
Published
2018-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KSKSolution, Stabilized Enzyme

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSKSolution, Stabilized EnzymeHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611969952199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611969952199076119699521997611969952199

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-224-6723techsupport.bmd@bio-rad.com

Regulatory Flags#

DUNS number
312576506
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07611969233786IH-5000015100015102019-07-05
07611969205493IH-10000011000011002017-01-20
07611969953066Lymphoflot8240128240122015-07-06
07611969953073Lymphostabil8240208240202015-07-06
07611969953080Hanks Solution8240358240352015-07-06
07611969953172Control-HLA (pos.)8241018241012015-07-01
07611969953189Control-HLA (neg.)8241068241062015-07-01
07611969953196Control-HLA-DR (pos.)8241108241102015-07-01
07611969953257HLA-A SSP Kit8262018262012015-07-01
07611969953264HLA-B SSP Kit8262068262062015-07-01
07611969953271HLA-C SSP Kit8262128262122015-07-01
07611969953288DRB SSP Kit8262158262152015-07-01
07611969953295DQB SSP Kit8262208262202015-07-01
07611969953301ABDR SSPtray8262308262302015-07-01
07611969953318ABC SSPtray8262408262402015-07-01
07611969965700Lymphoscreen ABC-608233002018-03-08
07611969965717Lymphoscreen DR 30x28233502018-03-08
03610522165049Wash Solution A Concentrate120126682020-02-05
07611969965304Washing Solution Concentrate8480000918480000912016-03-20
03610522136421IH-AbID12010902120109022022-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
23661562105452PapainDIAGASTKSK2018-05-01
10758750030330ORTHOTM Sera Papain ALBA BIOSCIENCE LIMITEDKSK2017-08-30
05060242471223ALBAzyme™ Papain Solution KitALBA BIOSCIENCE LIMITEDKSK2017-03-29
10888234000891Gamma-QuinIMMUCOR, INC.KSK2016-04-19
10888234001010W.A.R.M.IMMUCOR, INC.KSK2016-04-18
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