DEVICE: ImmunoCAP Allergen e88, Mouse epithelium, serum and urine proteins (07333066003061)

Device Identifier (DI) Information

ImmunoCAP Allergen e88, Mouse epithelium, serum and urine proteins
14-4327-01
In Commercial Distribution
14-4327-01
Phadia AB
07333066003061
GS1

1
354019424 *Terms of Use
ImmunoCAP Allergen e88, Mouse epithelium, serum and urine proteins
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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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
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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

3cc018e8-ae91-4731-a97e-2b000f029ae4
July 06, 2018
3
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

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

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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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