DEVICE: SAFECUP II MULTIDRUG 12 (00695684415228)

Device Identifier (DI) Information

SAFECUP II MULTIDRUG 12
41522
In Commercial Distribution

GERMAINE LABORATORIES, INC
00695684415228
GS1

25
176458115 *Terms of Use
Lateral flow immunoassay for the detection of drugs of abuse in urine. Flat-side cup for easy photocopying. Tests for COC, AMP, mAMP, THC, MTD, MDMA, OXY, OPI, PCP, BAR, BZO, TCA
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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?
55764 Propoxyphene IVD, kit, enzyme immunoassay (EIA)
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of propoxyphene in a clinical specimen, using an enzyme immunoassay (EIA) method.
Active false
30517 Barbiturate 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 barbiturates 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. It is not intended to be used for self-testing.
Active false
30521 Methadone 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 methadone 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. It is not intended to be used for self-testing.
Active false
30523 Phencyclidine (PCP) 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 phencyclidine (PCP) 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. It is not intended to be used for self-testing.
Active false
30518 Benzodiazepine group 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 benzodiazepine 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. It is not intended to be used for self-testing.
Active false
30516 Amphetamine-specific 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 a specific amphetamine 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. It is not intended to be used for self-testing.
Active false
30522 Opiate/opiate metabolite 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 opiate and/or opiate metabolites 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. It is not intended to be used for self-testing.
Active false
55498 Methamphetamine-specific 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 a specific methamphetamine 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. It is not intended to be used for self-testing.
Active false
30520 Cocaine/cocaine metabolite 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 cocaine and/or cocaine metabolites 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. It is not intended to be used for self-testing.
Active false
30519 Cannabinoid/cannabinoid metabolite 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 cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) 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. It is not intended to be used for self-testing.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DJR Enzyme Immunoassay, Methadone
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs
DIS Enzyme Immunoassay, Barbiturate
LCM Enzyme Immunoassay, Phencyclidine
JXM Enzyme Immunoassay, Benzodiazipine
DKZ Enzyme Immunoassay, Amphetamine
LAF Gas Chromatography, Methamphetamine
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
DJG Enzyme Immunoassay, Opiates
LDJ Enzyme Immunoassay, Cannabinoids
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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

a2d14e37-3ca7-455c-a25f-c7ce90fec6da
November 28, 2022
5
May 12, 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: 00695684415221 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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