DEVICE: VITROS (10758750006823)

Device Identifier (DI) Information

VITROS
6801733
In Commercial Distribution
6801733
ORTHO-CLINICAL DIAGNOSTICS, INC.
10758750006823
GS1

1
623873044 *Terms of Use
VITROS Chemistry Products IgG Reagent
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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?
53785 Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total immunoglobulin G (IgG total) in a clinical specimen, using a nephelometry/turbidimetry method.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CFN METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No 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
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Clinically Relevant Size

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

a4ac65dd-9597-4eea-88d3-289fa82aaa00
June 21, 2023
4
August 26, 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
20758750006820 36 10758750006823 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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