FDA.reportPublic FDA data

Anti-CD205

Primary DI
00840542210419
Brand
Anti-CD205
Company
BIOGENEX LABORATORIES
Model
NU737-5UCE
Catalog number
NU737-5UCE
Published
2026-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
00840542210419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840542210419008405422104198405422104190840542210419

GMDN Terms#

Term, Definition table
TermDefinition
Multiple CD cell marker IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of multiple cluster of differentiation (CD) cell markers in a clinical specimen, including associated percentage and/or enumeration of specific cell populations.

Regulatory Flags#

DUNS number
042697045
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00810119672421Anti-KRASAR751-5RAR751-5R2026-09-18
00840542207594Anti-CD2AM438-10MAM438-10M2026-09-18
00840542207600Anti-CD2AX438-50DAX438-50D2026-09-18
00840542207693Anti-Inhibin-AlphaAM446-10MAM446-10M2026-09-18
00840542207709Anti-Inhibin-AlphaAX446-50DAX446-50D2026-09-18
00840542207716Anti-Inhibin-AlphaAX446-YCDAX446-YCD2026-09-18
00840542210181Anti-CD90AN733-5MAN733-5M2026-09-18
00840542210198Anti-CD90AN733-10MAN733-10M2026-09-18
00840542210204Anti-CD90AY733-50DAY733-50D2026-09-18
00840542210211Anti-CD90AY733-YCDAY733-YCD2026-09-18
00840542210228Anti-CD90NU733-UCNU733-UC2026-09-18
00840542210235Anti-CD90NU733-5UCNU733-5UC2026-09-18
00840542210242Anti-CD53AN734-5MAN734-5M2026-09-18
00840542210259Anti-CD53AN734-10MAN734-10M2026-09-18
00840542210266Anti-CD53AY734-50DAY734-50D2026-09-18
00840542210372Anti-CD205AN737-10MEAN737-10ME2026-09-18
00840542210389Anti-CD205AY737-50DEAY737-50DE2026-09-18
00840542210396Anti-CD205AY737-YCDEAY737-YCDE2026-09-18
00840542210402Anti-CD205NU737-UCENU737-UCE2026-09-18
00840542210426Anti-CD103AN739-5MEAN739-5ME2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840542210372Anti-CD205BIOGENEX LABORATORIESMVU2026-09-18
00840542210389Anti-CD205BIOGENEX LABORATORIESMVU2026-09-18
00840542210396Anti-CD205BIOGENEX LABORATORIESMVU2026-09-18
00840542210402Anti-CD205BIOGENEX LABORATORIESMVU2026-09-18
00840542210600Anti-CD95BIOGENEX LABORATORIESMVU2026-09-18
00810034704399FITC anti-human Ki-67BIOLEGEND, INC.MVU2026-09-04
00810034704481PE anti-human CD366BIOLEGEND, INC.MVU2026-09-04
00810034703170PerCP anti-human CD61BIOLEGEND, INC.MVU2026-08-07
03661540953170DSQ Alert HT Adenovirus Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953187DSQ Alert HT Adenovirus Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953217DSQ Alert Hepatitis E Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953224DSQ Alert Hepatitis E Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953279DSQ Alert Mycoplasma pneumoniae Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953286DSQ Alert Mycoplasma pneumoniae Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
00810034704252FITC anti-human TNF-AlphaBIOLEGEND, INC.MVU2026-07-28
00810034704320PE anti-human IL-2BIOLEGEND, INC.MVU2026-07-28
00810227730211Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00850051429820Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00850051429837Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00850051429844Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00850051429851Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00810227730006Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730013Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730020Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730037Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429967Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429974Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429981Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429998Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730044Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21