DEVICE: Amplichek (03610520530061)

Device Identifier (DI) Information

Amplichek
12000528
In Commercial Distribution
12000528
BIO-RAD LABORATORIES, INC.
03610520530061
GS1

1
051624070 *Terms of Use
Amplichek I Level 1 (An assayed nucleic acid control.)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
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?
48218 HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid 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 human immunodeficiency virus 1 (HIV1) nucleic acid, Hepatitis C virus nucleic acid and/or Hepatitis B virus nucleic acid in a clinical specimen.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
PMN Assayed external control material for microbiology nucleic acid amplification (NAT) assays
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K152679 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 -70 and -20 Degrees Celsius
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Clinically Relevant Size

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

ac3f8036-17d5-4ac2-a6c7-0bf94896b0b9
January 31, 2023
5
September 19, 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(800)854-6737
qsd.techservice@bio-rad.com
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