DEVICE: ImmunoCAP Allergen t73, Australian pine (07333066003597)

Device Identifier (DI) Information

ImmunoCAP Allergen t73, Australian pine
14-4374-01
In Commercial Distribution
14-4374-01
Phadia AB
07333066003597
GS1

1
354019424 *Terms of Use
ImmunoCAP Allergen t73, Australian pine
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
53781 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 immunoglobulin E (IgE) antibodies to one or multiple allergen(s) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to screen for allergies associated with certain conditions (e.g., food intolerance).
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DHB SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K051218 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

d7e06218-a111-4835-923b-be6c801dc25a
August 03, 2023
5
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+469999999999
xx@xx.xx
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