DEVICE: PreKnow Pregnancy Test (25 hCG Strips) (00857275007100)

Device Identifier (DI) Information

PreKnow Pregnancy Test (25 hCG Strips)
ID1-S-25P
In Commercial Distribution

IDUN SOLUTIONS LLC
00857275007100
GS1

1
080651010 *Terms of Use
25 Test Strips; hCG Test Strips
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
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?
33819 Total human chorionic gonadotropin 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 total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, 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 to aid detection of pregnancy, or as a predictor of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome). It is not intended to be used for self-testing.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LCX Kit, Test, Pregnancy, Hcg, Over The Counter
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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
No storage/handling found
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Clinically Relevant Size

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

995bd9be-68ac-475e-ac90-af1e9756c82c
July 06, 2023
3
May 16, 2017
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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
00857275007001 25 00857275007100 In Commercial Distribution 25 HCG Strips
00857275007018 20 00857275007100 In Commercial Distribution 20 HCG Strips
10857275007015 60 00857275007018 In Commercial Distribution 60 Kits
10857275007008 120 00857275007001 In Commercial Distribution 120 Kits
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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

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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

[?]
No Customer Contact currently defined
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