DEVICE: QuickVue+ (30014613001799)

Device Identifier (DI) Information

QuickVue+
hCG S/U Test
In Commercial Distribution
00179
QUIDEL CORPORATION
30014613001799
GS1

1
079509836 *Terms of Use
QkVue+ hCG S/U, 90T
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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?
66850 Human chorionic gonadotropin beta-subunit IVD, kit, rapid ICT, clinical
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of the beta subunit on the intact HCG hormone and/or free beta subunit (beta-HCG) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses for early detection of pregnancy, as a predictive indicator of adverse pregnancy outcomes (e.g., miscarriage), or as an indicator of trisomy 21 (Down syndrome) during pregnancy. It is not intended to be used for self-testing.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JHI Visual, pregnancy hCG, prescription use
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K973858 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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

6dae40eb-f72a-4e8a-9ef9-0cbda16a4d64
December 05, 2024
6
September 14, 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(858)552-1100
technicalsupport@quidel.com
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