FDA.reportPublic FDA data

CD38-APC (Clone IB6)

Primary DI
04049934134210
Brand
CD38-APC (Clone IB6)
Company
Miltenyi Biotec B.V. & Co. KG
Model
170-081-038
Device description
IB6 recognizes the human CD38 antigen, a single-chain type II transmembrane glycoprotein with enzymatic activity. It is present on the majority of hematopoietic cells, prevalent during early differentiation and activation processes. Terminally differentiated B cells (plasma cells) express CD38 brightly. Furthermore, CD38 is constitutively expressed in several tissues, for example brain, muscle, and kidney.
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

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
04049934134210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049934134210040499341342104049934134210

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
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 DI, Brand, Model table
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03661540953118DSQ Alert Measles Primer Mix ASR, 48 rxnElitechgroup Mdx LLCMVU2026-03-24
03661540953125DSQ Alert Measles Probe Mix ASR, 48 rxnElitechgroup Mdx LLCMVU2026-03-24
03661540953132DSQ Alert RNase P Primer Mix ASR 48 rxnElitechgroup Mdx LLCMVU2026-03-24
03661540953163DSQ Alert RNase P Probe Mix ASR 48 rxnElitechgroup Mdx LLCMVU2026-03-24
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05055844935563CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935570CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
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