DEVICE: IDS-iSYS 17-OH Progesterone (05060169690738)

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Device Identifier (DI) Information

IDS-iSYS 17-OH Progesterone
IS-5100

IMMUNODIAGNOSTIC SYSTEMS LIMITED
05060169690738
GS1
1
No description.
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Progesterone IVD, kit, chemiluminescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of progesterone in a clinical specimen, using a chemiluminescent immunoassay method.
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FDA Product Code

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Product Code Product Code Name
JLS Radioimmunoassay, Progesterone
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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
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Store the cartridge and calibrators in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge or the calibrators.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
June 24, 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

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