FDA.reportPublic FDA data

CD25-PE

Primary DI
04049934134302
Brand
CD25-PE
Company
Miltenyi Biotec B.V. & Co. KG
Model
170-081-029
Device description
4E3 recognizes the human CD25 antigen, a 55 kDa glycoprotein also known as the low-affinity interleukin-2 receptor alpha chain (IL-2Rα). CD25 is expressed on activated T and B cells, on macrophages, and on a subset of non-activated CD4+ regulatory T cells. The CD25 antigen contains three epitope regions called A, B, and C. This CD25 antibody recognizes epitope region B.
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
04049934134302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049934134302040499341343024049934134302

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

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Primary DI, Brand, Company table
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