FDA.report

Lymphotype HLA-DR/DQ 72

Primary DI
07611969952885
Brand
Lymphotype HLA-DR/DQ 72
Company
Bio-Rad Medical Diagnostics GmbH
Model
823102
Catalog number
823102
Device description
for 6 detections of human HLA-DR/DQ antigens in the complement-dependent microlymphocytotoxicity test
Published
2015-07-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GKZCounter, Differential Cell

Product Code Classifications

CodeDeviceSpecialtyClass
GKZCounter, Differential CellHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07611969952885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07611969952885076119699528857611969952885

GMDN Terms

TermDefinition
HLA class II antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple HLA class II antigens in a clinical specimen, using a complement-dependent cytotoxicity (CDC) method.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-20 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
800-224-6723techsupport.bmd@bio-rad.com

Regulatory Flags

DUNS number
312576506
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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