FDA.report

Human CD3 Alexa Fluor® 700 Conjugate

Primary DI
10190302008488
Brand
Human CD3 Alexa Fluor® 700 Conjugate
Company
LIFE TECHNOLOGIES CORPORATION
Model
CD0329
Published
2018-03-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
MVUREAGENTS,SPECIFIC,ANALYTE

Product Code Classifications

CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10190302008488PrimaryGS10

GMDN Terms

TermDefinition
CD3 cell marker IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of CD3 cell marker in a clinical specimen.

Sterilization Methods

Method

Regulatory Flags

DUNS number
080131636
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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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