FDA.reportPublic FDA data

CD27-VioBlue

Primary DI
04049934134081
Brand
CD27-VioBlue
Company
Miltenyi Biotec B.V. & Co. KG
Model
170-081-051
Device description
M-T271 recognizes CD27, a member of the tumor necrosis factor receptor family. CD27 is expressed at differing levels on memory B cells, a fraction of plasma cells, and on naive and memory T cells, but is not expressed on naive B cells or effector T cells. It is also expressed on NK cells. CD27 therefore represents a useful marker to distinguish certain T and B cell subsets from each other.
Published
2021-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVUReagents, Specific, Analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049934134081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049934134081040499341340814049934134081

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify002 - 8 °C Protected from light.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-367-6227technicalsupportUS@miltenyi.com

Regulatory Flags#

DUNS number
342920388
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049934004674CliniMACS PBS/EDTA Buffer 1L70026700-252016-07-22
04049934000270CryoMACS® Freezing Bag 5074400200-074-4002017-12-18
04049934000287CryoMACS® Freezing Bag 25074401200-074-4012016-07-22
04049934000294CryoMACS® Freezing Bag 50074402200-074-4022016-07-22
04049934000300CryoMACS® Freezing Bag 75074403200-074-4032016-07-22
04049934000317CryoMACS® Freezing Bag 100074404200-074-4042016-07-22
04049934004636CliniMACS Plus Instrument75101151-012015-03-26
04049934004827CliniMACS CD34 Reagent70103171-012015-03-26
04049934004834CliniMACS Tubing Set TS73105161-012016-07-22
04049934004841CliniMACS Tubing Set LS73205162-012015-03-26
040499341337257-AAD Staining Solution170-081-0882021-03-26
04049934133732CD45RA-FITC170-081-0862021-03-26
04049934133749Anti-TCRg/d-PE-Vio770170-081-0852021-03-26
04049934133756CD4-VioGreen (Clone REA623)170-081-0842021-03-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08595715450544CyFlow™ CD200 PE-Cy7EXBIO Praha, a.s.MVU2025-10-01
08719327450949Anti-HbF PUREIQ Products B.V.MVU2023-01-26
08719327450956Anti-HbF FITCIQ Products B.V.MVU2023-01-26
08719327450963Anti-HbF R-PEIQ Products B.V.MVU2023-01-26
08719327450970Anti-HbF Dy-410IQ Products B.V.MVU2023-01-26
08719327450987anti-HbS PUREIQ Products B.V.MVU2023-01-26
08719327450994anti-HbS FITCIQ Products B.V.MVU2023-01-26
08719327451014CD163 PURE IQ Products B.V.MVU2023-01-26
08719327451021CD163 FITCIQ Products B.V.MVU2023-01-26
08719327451038CD163 R-PEIQ Products B.V.MVU2023-01-26
08719327451045CD163 BiotinIQ Products B.V.MVU2023-01-26
08719327451052CD64 PUREIQ Products B.V.MVU2023-01-26
08719327451069CD64 CyQIQ Products B.V.MVU2023-01-26
08719327451076CD64 FITCIQ Products B.V.MVU2023-01-26
08719327451083CD64 R-PEIQ Products B.V.MVU2023-01-26
08719327451090CD64 R-PEIQ Products B.V.MVU2023-01-26
08436548983413CD38-multi-epitope-FITCCYTOGNOS SLMVU2023-01-17
08436548984946CD45-APC-C750™CYTOGNOS SLMVU2023-01-17
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10190302007283PRIMER 100 NMOL DRYLIFE TECHNOLOGIES CORPORATIONMVU2018-09-18
10190302009492Mouse IgM Purified AntibodyLIFE TECHNOLOGIES CORPORATIONMVU2018-07-02
10190302009508Mouse IgM FITC ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-07-02
10190302009515Mouse IgM R-PE ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-07-02
10190302010405Human CD14 TRI-COLOR® ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-05-06
10190302010412Human CD14 Biotin ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-05-06
10190302010429Human CD14 PE-Texas Red® ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-05-06
10190302010436Human CD14 PE-Cy®5.5 ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-05-06
10190302010443Human CD14 APC- Alexa Fluor® 750 Conj.LIFE TECHNOLOGIES CORPORATIONMVU2018-05-06
10190302010450Human CD14 Pacific Blue™ ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-05-06
10190302010467Human CD14 Alexa Fluor® 700 ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-05-06