DEVICE: JAS Diagnostics (00817274021774)

Device Identifier (DI) Information

JAS Diagnostics
XL-A1C2-30
In Commercial Distribution

DREW SCIENTIFIC, INC.
00817274021774
GS1

1
144968104 *Terms of Use
HEMOGLOBIN A1C REAGENT, (2x 30mL R1, 2x 9.5mL R2a, 2x 0.5mL R2b)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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?
52209 Cryptosporidium parvum immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to the parasitic protozoan Cryptosporidium parvum in a clinical specimen.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LCP Assay, Glycosylated Hemoglobin
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K031539 000
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

2e9c668a-f5bb-41e0-a421-942f801fe86d
August 09, 2021
4
September 09, 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
No
No
No CLOSE

Customer Contact

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