FDA.report

CD4-VioGreen (Clone REA623)

Primary DI
04049934133756
Brand
CD4-VioGreen (Clone REA623)
Company
Miltenyi Biotec B.V. & Co. KG
Model
170-081-084
Device description
REA623 recognizes the human CD4 antigen, a 55 kDa single-pass type I membrane protein, also known as T4/Leu-3. CD4 is highly expressed on T helper cells and at a lower level on monocytes and dendritic cells. It is involved in the recognition of MHC class ll/peptide complexes by the TCR heterodimers and is the receptor for the human immunodeficiency virus (HIV). Additional information: Clone REA623 displays negligible binding to Fc receptors.
Published
2021-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MVUReagents, Specific, Analyte

Product Code Classifications

CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049934133756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049934133756040499341337564049934133756

GMDN Terms

TermDefinition
Assay development analyte-specific reagent IVDAn antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological specimen for the development of a laboratory developed test (LDT) or commercial in vitro diagnostic medical device (IVD). Commonly referred to as an analyte specific reagent (ASR), it is neither labelled with instructions for use nor diagnostic or performance claims.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify002 - 8 °C Protected from light.

Sterilization Methods

Method

Contacts

PhoneEmail
800-367-6227technicalsupportUS@miltenyi.com

Regulatory Flags

DUNS number
342920388
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
040499341337257-AAD Staining Solution170-081-0882021-03-26
04049934133732CD45RA-FITC170-081-0862021-03-26
04049934133749Anti-TCRg/d-PE-Vio770170-081-0852021-03-26
04049934133763CD197-VioBlue170-081-0832021-03-26
04049934133770CD62L-PE-Vio770170-081-0822021-03-26
04049934133787CD62L-VioGreen170-081-0812021-03-26
04049934133794CD45RA-VioBlue170-081-0802021-03-26
04049934133800CD34-VioBlue170-081-0792021-03-26
04049934133817CD45-VioGreen (Clone REA747)170-081-0782021-03-26
04049934133824CD45-VioBlue (Clone REA747)170-081-0772021-03-26
04049934133831CD19-PE-Vio770170-081-0762021-03-26
04049934133848CD8-APC-Vio770 (Clone REA734)170-081-0752021-03-26
04049934133855CD20-PE-Vio770170-081-0742021-03-26
04049934133862CD8-APC-Vio770 (Clone BW135/80)170-081-0732021-03-26
04049934133879CD14-APC170-081-0722021-03-26
04049934133886Anti-TCRg/d-PE170-081-0712021-03-26
04049934133893Anti-TCRa/b-APC (Clone REA652)170-081-0702021-03-26
04049934133909Anti-TCRa/b-PE (Clone REA652)170-081-0692021-03-26
04049934133916CD38-APC (Clone REA671)170-081-0682021-03-26
04049934133923CD19-APC 170-081-0672021-03-26

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