DEVICE: VITROS (10758750034833)

Device Identifier (DI) Information

VITROS
6177747
In Commercial Distribution
6177747
ORTHO CLINICAL DIAGNOSTICS
10758750034833
GS1

1
215865786 *Terms of Use
VITROS Immunodiagnostic Products CA 19-9 Reagent Pack
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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?
60976 Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 19-9 (CA19-9) in a clinical specimen, using a chemiluminescent immunoassay method. CA19-9 is typically used as a marker commonly associated with gastrointestinal, pancreatic, bile duct and gallbladder cancer.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NIG SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K231525 000
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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: Do not freeze
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Clinically Relevant Size

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

78bae091-8df5-4792-894b-3f6f66764dcc
May 03, 2024
1
April 25, 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
20758750034830 30 10758750034833 In Commercial Distribution Case
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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

[?]
No Customer Contact currently defined
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