FDA.report

CD11b-APC

Primary DI
04049934134418
Brand
CD11b-APC
Company
Miltenyi Biotec B.V. & Co. KG
Model
170-081-018
Device description
M1/70.15.11.5 recognizes the human, mouse, and non-human primate CD11b antigen. CD11b, also known as Mac-1 alpha or integrin alphaM chain, is part of the CD11b/CD18 heterodimer (Mac-1 alpha, Mbeta2 integrin), also known as the C3 complement receptor. It functions as a receptor for complement (C3bi), fibrinogen, or clotting factor X. In humans, CD11b is strongly expressed on myeloid cells and weakly expressed on NK cells and some activated lymphocytes as well as on microglia in the brain. In mice, the CD11b antigen is expressed on monocytes/macrophages and microglia. To a lower extent it is expressed on granulocytes, NK cells, CD5+ B-1 cells, and subsets of dendritic 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
04049934134418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049934134418040499341344184049934134418

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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04049934133824CD45-VioBlue (Clone REA747)170-081-0772021-03-26
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04049934133862CD8-APC-Vio770 (Clone BW135/80)170-081-0732021-03-26
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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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