DEVICE: IDS-iSYS 17-OH Progesterone Calibration Verifiers (05060169691070)

Device Identifier (DI) Information

IDS-iSYS 17-OH Progesterone Calibration Verifiers
IS-5135
In Commercial Distribution

IMMUNODIAGNOSTIC SYSTEMS LIMITED
05060169691070
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
Progesterone IVD, calibrator A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of progesterone 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 [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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: Leave the controls at room temperature for 10 minutes and gently mix the bottles by hand before use. Care should be taken to avoid the formation of foam.
Storage 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

4e7d5cd2-8d87-407e-85e4-1065829c7a65
March 29, 2018
2
June 24, 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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