DEVICE: CELL-DYN (00380740017071)

Device Identifier (DI) Information

CELL-DYN
08H57-01
In Commercial Distribution
08H5701
ABBOTT LABORATORIES
00380740017071
GS1

1
079226220 *Terms of Use
CELL-DYN HemCal Plus Calibrator
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Full blood count IVD, calibrator A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count and calculation of red cell parameters and/or platelet count.
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FDA Product Code

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Product Code Product Code Name
KRY CALIBRATOR FOR PLATELET COUNTING
KRX CALIBRATOR FOR CELL INDICES
KSA CALIBRATOR FOR RED-CELL AND WHITE-CELL COUNTING
KRZ CALIBRATOR FOR HEMOGLOBIN AND HEMATOCRIT MEASUREMENT
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K020469 000
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 2 and 10 Degrees Celsius
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Clinically Relevant Size

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

2405f097-e3ba-457e-8419-728962cd7182
July 06, 2018
3
June 06, 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

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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)422-2688
xx@xx.xx
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