DEVICE: Alere Determine HIV-1/2 Ag/Ab Combo Controls (07290015003759)

Device Identifier (DI) Information

Alere Determine HIV-1/2 Ag/Ab Combo Controls
Alere Determine HIV-1/2 Ag/Ab Combo Cont
In Commercial Distribution
7D2628
Orgenics Ltd
07290015003759
GS1

1
600022628 *Terms of Use
Contents HIV-1 Reactive Control, 1.5 mL HIV-2 Reactive Control, 1.5 mL P24 Antigen Control, 1.5 mL HIV Nonreactive Control, 1.5 mL
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
Yes
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
HIV1/HIV2 antigen/antibody IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from and antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen.
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FDA Product Code

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Product Code Product Code Name
No Product Codes
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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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 8 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

d433d2b3-af8a-44c7-a039-d7c6c5b4f5be
March 29, 2018
2
September 24, 2014
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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(877)866-9335
ts.scr@alere.com
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