DEVICE: IDS Beta CrossLaps® (CTX-I) (05060169695986)

Device Identifier (DI) Information

IDS Beta CrossLaps® (CTX-I)
IS-3000N
In Commercial Distribution

IMMUNODIAGNOSTIC SYSTEMS LIMITED
05060169695986
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© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
53643 Procollagen type I C-terminal propeptide (PICP) IVD, reagent
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of procollagen type I C-terminal propeptide (PICP) in a clinical specimen.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JMM Column Chromatography & Color Development, Hydroxyproline
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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

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Store in an upright position.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

e9173fa2-03e4-4d25-9ebe-a51645e89c97
January 11, 2024
1
January 03, 2024
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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

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

[?]
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
techsupport.uk@idsplc.com
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