DEVICE: IDS-iSYS Insulin like Growth Factor-I (IGF-1) Calibration Verifiers (05060169690981)

Device Identifier (DI) Information

IDS-iSYS Insulin like Growth Factor-I (IGF-1) Calibration Verifiers
IS-3935
In Commercial Distribution

IMMUNODIAGNOSTIC SYSTEMS LIMITED
05060169690981
GS1

1
494268600 *Terms of Use
No description.
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, calibrator A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of insulin- like growth factor binding protein 1 (IGFBP-1) in a clinical specimen.
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FDA Product Code

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Product Code Product Code Name
JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K122141 000
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Sterilization

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

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Storage and Handling
Special Storage Condition, Specify: Store upon receipt at 2 to 8 degrees celsius
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Handling Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

2d8c6359-020e-4cb0-a04a-f11276edc0f1
July 06, 2018
3
April 01, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+4401915190660
info.uk@idsplc.com
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