DEVICE: IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) (05060169690301)

Device Identifier (DI) Information

IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3)
IS-4400
In Commercial Distribution

IMMUNODIAGNOSTIC SYSTEMS LIMITED
05060169690301
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

[?]

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 3 (IGFBP-3) IVD, kit, chemiluminescent immunoassay A collection of reagents and other associated materials intended to be used for the quantitative measurement of insulin-like growth factor binding protein 3 (IGFBP-3) 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
CFL Radioimmunoassay, Human Growth Hormone
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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
Handling Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Prior to first use. Store the cartridge and calibrators in the upright position in the dark. Do not freeze the cartridge.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

4ecf0f79-b4d9-4cb3-96ad-b34895c01280
March 29, 2018
2
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)

[?]
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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