FDA.reportPublic FDA data

FLEX Mono Mo A-Hu CD45, Leucocyte Common Antigen Cls 2B11 + PD7/26 RTU

Primary DI
05700572029229
Brand
FLEX Mono Mo A-Hu CD45, Leucocyte Common Antigen Cls 2B11 + PD7/26 RTU
Company
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
Model
IS751
Device description
FLEX Monoclonal Mouse Anti-Human CD45, Leucocyte Common Antigen Clones 2B11 + PD7/26 Ready-to-Use (Dako Autostainer/ Autostainer Plus)
Published
2020-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700572029229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700572029229057005720292295700572029229

GMDN Terms#

Term, Definition table
TermDefinition
CD45 leukocyte common antigen 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 CD45 leukocyte common antigen cell marker in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4544859500dako.dkregulatory@agilent.com
+1-800-227-9770Global.RA@agilent.com

Regulatory Flags#

DUNS number
894671143
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05700572515890Mono Mo A-Hu CD34 Class III/FITC Cl BIRMA-K3F70812020-09-17
05700572005049Mono Mo A-Rb Immunoglobulins Cl MR12/53M07372020-09-17
05700572005339Mono Mo A-Hu Amyloid A Cl mc1M07592020-09-17
05700572006428Mono Mo A-Hu Carcinoembryonic Antigen Cl II-7M70722020-09-17
05700572005100Mono Mo A-Hu CD45R0 Cl UCHL1M07422016-09-16
05700572005599Mono Mo A-Hu Prostatic Acid Phosphatase Cl PASE/4LJM07922020-09-17
05700572006305Mono Mo A-Cytokeratin 17 Cl E3M70462020-09-17
05700572018735Ig Reagent Rb F(ab')2/APCX09982020-09-17
05700572024613Mono Mo A-Hu CD22/APC Cl 4KB128C72812020-09-17
05700572024774Mono Mo a Hu CD61, Platelet Glycoprotein IIIa/APC, Cl Y2/51C72802020-09-17
05700572033929Mono Mo a Hu CD45R0/RPE, Cl UCHL1R08432020-09-17
05700572033936Mono Mo a Hu CD3/PB, Cl UCHT1PB9822020-09-17
05700572033950Mono Mo a Hu CD8/PB, Cl DK25PB9842020-09-17
05700572515258Mono Mo a Hu CD41, Platelet Glycoprotein IIb/RPE, Cl 5B12R70582020-09-17
05700572515432Mono Mo a Hu CD79ß/RPE, Cl SN8R72722020-09-17
05700572515715Mono Mo A-Hu CD7/FITC Cl DK24F07892020-09-17
05700572515746Mono Mo A-Hu CD25, Interleukin-2 Receptor/FITC Cl ACT-1F08012020-09-17
05700572516255Mono Mo a Hu CD5/RPE, Cl DK23R08422020-09-17
05700572516279Mono Mo a Hu CD14/RPE, Cl TÜK4R08642020-09-17
05700572516309Mono Mo a Hu CD16, Fc Gamma Receptor III/RPE, Cl DJ130cR70122020-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055331340900BONDLEICA BIOSYSTEMS NEWCASTLE LTDNJT2026-09-25
05055331340917BONDLEICA BIOSYSTEMS NEWCASTLE LTDNJT2026-09-25
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00810119672926Anti-Heat Shock Protein 27 (HSP 27)BIOGENEX LABORATORIESNJT2026-09-22
00810119673206Anti-Collagen IIIBIOGENEX LABORATORIESNJT2026-09-22
00810119674463Anti-Beta-Tubulin IIBIOGENEX LABORATORIESNJT2026-09-22
00810119674531Anti-Beta-Tubulin IVBIOGENEX LABORATORIESNJT2026-09-22
00810119675996Anti-Beta-Tubulin IVBIOGENEX LABORATORIESNJT2026-09-22
00810119676016Anti-Beta-Tubulin IIIBIOGENEX LABORATORIESNJT2026-09-22
00810119679000Anti-Collagen IIIBIOGENEX LABORATORIESNJT2026-09-22
00810119679277Anti-Beta-Tubulin IVBIOGENEX LABORATORIESNJT2026-09-22
00840542202629Anti-Alpha-TubulinBIOGENEX LABORATORIESNJT2026-09-22
00840542202636Anti-Alpha-TubulinBIOGENEX LABORATORIESNJT2026-09-22
00840542202650Anti-Alpha-TubulinBIOGENEX LABORATORIESNJT2026-09-22
00840542202667Anti-Alpha-TubulinBIOGENEX LABORATORIESNJT2026-09-22
00840542203138Anti-CDw75 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203145Anti-CDw75 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203152Anti-CDw75 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203169Anti-CD74 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203176Anti-CD74 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203183Anti-CD74 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203190Anti-CD74 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203206Anti-CD74 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203213Anti-CD74 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203268Anti-CD45RC (T Cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203275Anti-CD45RC (T Cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203282Anti-CD45RC (T Cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203299Anti-CD45RC (T Cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203305Anti-CD45RC (T Cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203312Anti-CD45RC (T Cell)BIOGENEX LABORATORIESNJT2026-09-22