DEVICE: STAT-Site M B-HB Strips (00657498000090)

Device Identifier (DI) Information

STAT-Site M B-HB Strips
401010
In Commercial Distribution
401010
STANBIO LABORATORY, L.P.
00657498000090
GS1

40
045361136 *Terms of Use
The STAT-Site® M β-HB Test is intended for the quantitative determination of the ketone body β-Hydroxybutyrate in serum or plasma using the STAT-Site® M β-HB Analyzer (Catalog #400400). The STAT-Site® M β-HB Test may be used with adults, infants, and children. For laboratory use only.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
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?
56681 Single-channel clinical chemistry analyser IVD, point-of-care
A mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative determination of one or multiple clinical chemistry analytes in a clinical specimen. Analytes measured include multiple clinical chemistry analytes such as glucose, ketone, specific proteins, clinical chemistry substrates, enzymes and/or a lipid profile, using a single technology such as electrometry, spectrophotometry, fluorimetry, radiometry or chemiluminescence.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
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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 30 Degrees Celsius
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Clinically Relevant Size

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

ff154bf4-9969-4185-8284-5c7db30c89b0
April 16, 2018
3
September 24, 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: 00657498001868 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
18005315535
stanbiolab@ekfdiagnostics.com
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