DEVICE: ARCHITECT (00380740003876)

Device Identifier (DI) Information

ARCHITECT
2P36-01
In Commercial Distribution
02P3601
Abbott GmbH & Co. KG
00380740003876
GS1

1
315786293 *Terms of Use
ARCHITECT HIV Ag/Ab Combo Calibrator
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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
HIV1/HIV2 antigen/antibody IVD, calibrator A material which is used to establish known points of reference for 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
MZF Test, hiv detection
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
BP090080 3
BP090080 5
BP090080 8
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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

6d96c8cd-3b86-4520-87bf-9234eee04454
July 06, 2018
3
January 31, 2015
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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

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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

[?]
+1(877)422-2688
xxx@xxx.xxx
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