FDA.report

ImmunoCAP Allergen Rf307, Hake

Primary DI
07333066008141
Brand
ImmunoCAP Allergen Rf307, Hake
Company
Phadia AB
Model
14-5194-10
Catalog number
14-5194-10
Device description
ImmunoCAP Allergen Rf307, Hake
Published
2020-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MVUReagents, specific, analyte

Product Code Classifications

CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07333066008141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07333066008141073330660081417333066008141

GMDN Terms

TermDefinition
Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of an allergen-specific immunoglobulin E (IgE) antibody in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+469999999999xx@xx.xx

Regulatory Flags

DUNS number
354019424
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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07333066021362EliA ANA 3 Positive Control 2500/500083-0041-2183-0041-212022-04-07

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