DEVICE: BD Calibrite™ (00382903404971)

Device Identifier (DI) Information

BD Calibrite™
340497
Not in Commercial Distribution
340497
BECTON, DICKINSON AND COMPANY
00382903404971
GS1
June 01, 2017
1
024230633 *Terms of Use
Calibrite PerCP Beads 25 Tests IVD
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Flow cytometer calibration/verification solution IVD A solution containing beads or particles with known optical and physical characteristics (e.g., antibodies conjugated with fluorescent dyes, specified size or other label) intended to be used to verify and/or optimize the performance of a flow cytometer or similar single/multichannel instrument. Verification/optimization functions may include optical density (absorbance), fluorescent or luminescent accuracy and compensation, linearity, repeatability, sensitivity, limit of detection and/or light scatter readings at specified wavelengths, and the ability to verify optical alignment and precision of the instrument or analyser. Solutions are typically single-use.
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FDA Product Code

[?]
Product Code Product Code Name
GKZ Counter, differential cell
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K961623 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
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Clinically Relevant Size

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

bd6950b9-2bf7-46e3-b41a-2271416ce859
July 06, 2018
3
June 08, 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

[?]
+1(877)232-8995
BDBCustomerService@bd.com
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