DEVICE: Ostase®+ BAP EIA (05060169690059)

Device Identifier (DI) Information

Ostase®+ BAP EIA
AC-20F1
In Commercial Distribution

IMMUNODIAGNOSTIC SYSTEMS LIMITED
05060169690059
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
Bone alkaline phosphatase (BALP) IVD, kit, chemiluminescent immunoassay A collection of reagents and other associated materials intended to be used for the quantitative measurement of bone alkaline phosphatase (BALP) in a clinical specimen, using a chemiluminescent immunoassay method.
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FDA Product Code

[?]
Product Code Product Code Name
CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K972666 000
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Sterilization

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

[?]
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

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

b32a3471-68f5-4cc1-8d32-d93727e7b71f
July 06, 2018
3
April 01, 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

[?]
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
info.uk@idsplc.com
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