FDA.report

TOX/See

Primary DI
00847817000690
Brand
TOX/See
Company
BIO-RAD LABORATORIES, INC.
Model
194-5184
Catalog number
1945184
Device description
TOX/See Drug Screen Test AMP
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DKZENZYME IMMUNOASSAY, AMPHETAMINE

Product Code Classifications

CodeDeviceSpecialtyClass
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00847817000690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00847817000690008478170006908478170006900847817000690

GMDN Terms

TermDefinition
Amphetamine-specific IVD, kit, immunochromatographic test (ICT), rapidA 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. This test is commonly used in the laboratory or in point-of-care analyses.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)224-6723diagcs@bio-rad.com

Regulatory Flags

DUNS number
132528295
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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03610522162260Geenius12012484120124842023-07-28
03610522168064Geenius12012851120128512023-07-28

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B298307220DrugCheck Express Diagnostic Int'l, Inc.DKZ2026-02-19
B298605010DrugCheck Express Diagnostic Int'l, Inc.DKZ2026-02-19
10810173655665HealgenHealgen Scientific Limited Liability CompanyDKZ2026-01-30
B298606220DrugCheck Express Diagnostic Int'l, Inc.DKZ2025-12-09
00841824105706N/AW.H.P.M. INC.DKZ2025-12-04
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00841824105683EZ CLICKW.H.P.M. INC.DKZ2025-11-20
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00850076289010Hysen Drug Test CardsHYSEN INC.DKZ2025-08-04
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00858886006841Noble Drug Test Cup (Urine)NOBLE MEDICAL INCDKZ2025-01-17
10815845024381SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.DKZ2024-12-17
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10840050517526Precision Plus Multi Panel Urine Drug Test CupADVIN BIOTECH, INC.DKZ2024-05-23
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