DEVICE: JAS Diagnostics (00081727402252)

Device Identifier (DI) Information

JAS Diagnostics
HDL4-125
In Commercial Distribution
HDL4-125
DREW SCIENTIFIC, INC.
00081727402252
GS1

1
144968104 *Terms of Use
HDL CHOLESTEROL (2x 125mL R1, 2x 42mL R2)
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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
High density lipoprotein (HDL) cholesterol IVD, kit, mass spectrometry A collection of reagents and other associated materials intended to be used for the quantitative measurement of high density lipoprotein (HDL) cholesterol lipid in a clinical specimen, using a mass spectrometry method.
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FDA Product Code

[?]
Product Code Product Code Name
LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
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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

158efa40-3d54-486e-94d3-bf711467a10a
March 29, 2018
2
October 11, 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

[?]
1-305-324-2300
customerservice@erbadiagnostics.com
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