FDA.report

Poly Rb A-Hu Beta-2-Microglobulin

Primary DI
05700572000501
Brand
Poly Rb A-Hu Beta-2-Microglobulin
Company
Dako Denmark ApS
Model
A0072
Device description
Polyclonal Rabbit Anti-Human Beta-2-Microglobulin
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JZGSYSTEM, TEST, BETA-2-MICROGLOBULIN IMMUNOLOGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
JZGSystem, Test, Beta-2-Microglobulin ImmunologicalImmunology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05700572000501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05700572000501057005720005015700572000501

GMDN Terms

TermDefinition
Beta-2-microglobulin 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 beta-2-microglobulin in a clinical specimen.

Device Sizes

TypeValueUnit
Total Volume2Milliliter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

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

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00850392007619BioCheck Beta-2 Microglobulin EIA Test KitBIOCHECK, INC.JZG2019-10-08
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00380740153601AlinityABBOTT LABORATORIESJZG2019-01-04
00816426021280K-ASSAY® Beta-2 Microglobulin ReagentKAMIYA BIOMEDICAL COMPANY, LLCJZG2018-12-19
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