FDA.report

Lymphotype HLA-B27 special

Primary DI
07611969952908
Brand
Lymphotype HLA-B27 special
Company
Bio-Rad Medical Diagnostics GmbH
Model
823110
Catalog number
823110
Device description
for 18 detections of human HLA-B27 antigen 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
MZITest,Qualitative,For Hla,Non-Diagnostic

Product Code Classifications

CodeDeviceSpecialtyClass
MZITest, Qualitative, For Hla, Non-DiagnosticUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07611969952908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07611969952908076119699529087611969952908

GMDN Terms

TermDefinition
HLA class I 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 I 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
false
No natural rubber latex
false
Sterilization required before use
false

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