FDA.reportPublic FDA data

Poly Rb A-Hu IgG/FITC Rb F(ab')2

Primary DI
05700572031925
Brand
Poly Rb A-Hu IgG/FITC Rb F(ab')2
Company
Dako Denmark ApS
Model
F0185
Device description
Polyclonal Rabbit Anti-Human IgG/FITC Rabbit F(ab')2
Published
2020-09-17
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
05700572031925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700572031925057005720319255700572031925

GMDN Terms#

Term, Definition table
TermDefinition
Total immunoglobulin G (IgG total) 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 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
305047466
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
05700571106938FLEX Mono Rb A-Hu Cyclin D1, Cl EP12, RTU (Dako Omnis)GA0832020-09-17
05700571107034FLEX Mono Mo A-Hu Mammaglobin Cl 304-1A5 RTU (Dako Omnis)GA0742020-09-17
05700571107041FLEX Mono Mo A-Hu Renal Cell Carcinoma Marker, Cl SPM314, RTU (Dako Omnis)GA0752020-09-17
05700571107065FLEX Mono Mo A-Hu Caldesmon, Cl h-CD, RTU (Dako Omnis)GA0542020-09-17
05700571108451Artisan Link ProAR3102020-09-17
05700571112571Dako CoverStainerCS1002020-09-17
05700572013693EasyLyse Erythrocyte-Lysing ReagentS23642020-09-17
05700572000211Poly Rb A-Hu PrealbuminA00022020-09-17
05700572000334Poly Rb A-Hu TauA00242020-09-17
05700572000686Poly Rb A-Hu Lysozyme EC 3.2.1.17A00992020-09-17
05700572000969Poly Rb A-Hu SerumA02062020-09-17
05700572001089Poly Rb A-Hu ThyroglobulinA02512020-09-17
05700572001379Poly Rb A-Hu IgGA04232020-09-17
05700572001409Poly Rb A-Hu IgMA04252020-09-17
05700572001461Poly Rb A-Hu CD3A04522020-09-17
05700572001539Poly Rb A-Hu CalcitoninA05762020-09-17
05700572001690Poly Rb A-Escherichia ColiB03572020-09-17
05700572002376Poly Rb A-Hu Fibrinogen/FITCF01112020-09-17
05700572002697Poly Rb A-Hu IgG/FITC Rb F(ab')2F03152020-09-17
05700572003373Mono Mo A-Hu CD68/FITC Cl KP1F71352020-09-17

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