FDA.reportPublic FDA data

Ig Reagent Rb F(ab')2/APC

Primary DI
05700572018735
Brand
Ig Reagent Rb F(ab')2/APC
Company
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
Model
X0998
Device description
Ig Reagent Rabbit F(ab')2/APC
Published
2020-09-17
Public version status
Update
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
05700572018735PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700572018735057005720187355700572018735

GMDN Terms#

Term, Definition table
TermDefinition
Total immunoglobulin G (IgG total) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of total immunoglobulin G (IgG total) in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4544859500dako.dkregulatory@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
05700572033028DakoGA6332026-05-15
05700572033127DakoGA6142026-05-16
05700572033363DakoGA6282026-05-15
05700572034230DakoGA6272026-05-16
05700572005322Mono Mo A-Hu Serotonin Cl 5HT-H209M07582020-09-17
05700574035631Alissa InterpretK5849AA2022-07-11
05700572027799Poly Rb A-Hu Alpha-1-FetoproteinA00082020-09-17
05700572005841Mono Mo A-Hu CD35 Cl Ber-MAC-DRCM08462020-09-17
05700572004912Mono Mo A-Vimentin Cl V9M07252020-09-17
05700572027942Mono Mo A-Vimentin Cl V9M07252020-09-17
05700572516170Mono Mo A-Epstein-Barr Virus, LMP Cls CS. 1-4M08972020-09-17
05700571112182DakoGC1182025-09-02
05700575013812Dako Omnis DI Water Filling AccessoriesGC1212025-06-25
05700575014017Dako Omnis Clean Liquid System HardwareGC1222025-06-25
05700575014031Dako Omnis Waste Tank (NHz)GC1262025-06-25
05700575014048Dako Omnis Waste Tank (Hz)GC1272025-06-25
05700575014413Dako Omnis Waste Accessories (Direct)GC1232025-06-25
05700575014420Dako Omnis Waste Accessories (Indirect)GC1242025-06-25
05700572007340Poly Rb A-Hu IgG/HRPP02142016-09-16
05700575000416Dako Omnis 165 DuoGI1002025-07-01

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