FDA.report

CD44-FITC

Primary DI
04049934134272
Brand
CD44-FITC
Company
Miltenyi Biotec B.V. & Co. KG
Model
170-081-032
Device description
DB105 recognizes the CD44 antigen. CD44 is a marker for many types of cancer stem cells (CSC), including breast CSCs that possess higher tumorigenicity and metastatic potential, colorectal, pancreatic, and prostate CSCs. In addition, expression was observed in several cancers as well as on carcinoma cell lines. Here, CD44 plays a role in cancer cell migration and matrix adhesion in response to a cellular microenvironment, thus enhancing cellular aggregation and tumor cell growth. CD44 is also expressed on mesodermal cells, such as hematopoietic, fibroblastic, and glial cells.
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
04049934134272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049934134272040499341342724049934134272

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

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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
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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

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