FDA.reportPublic FDA data

TOX/See

Primary DI
00847817000751
Brand
TOX/See
Company
BIO-RAD LABORATORIES, INC.
Model
194-5204
Catalog number
1945204
Device description
TOX/See Drug Screen Test PPX
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JXNENZYME IMMUNOASSAY, PROPOXYPHENE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXNEnzyme Immunoassay, PropoxypheneClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847817000751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847817000751008478170007518478170007510847817000751

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse 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 one or multiple drugs of abuse 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#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)224-6723diagcs@bio-rad.com

Regulatory Flags#

DUNS number
132528295
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847661000778Lyphochek7447442016-09-12
00847661000785Lyphochek7457452016-09-12
00847661000792Lyphochek7467462016-09-12
00847661001027Lyphochek5975972016-09-12
00847661001034Lyphochek5985982016-09-12
00847661001041Lyphochek5995992016-09-12
00847661001898Lyphochek598X598X2016-09-12
00847661001959Lyphochek745X745X2016-09-12
0361052031061896AN96AN-BPU-QUEST96AN-BPU-QUEST2016-09-12
03610520547663ANA PLATE196AN-BPU196AN-BPU2016-09-12
0361052056045796AN96AN-BPU-TRINITY96AN-BPU-TRINITY2016-09-12
03610520569184ANA PLATE196AN-BPU-ED196AN-BPU-ED2016-09-12
00847661000082Liquichek1071072016-09-12
00847661000099Liquichek1081082016-09-12
00847661000105Liquichek1111112016-09-12
00847661000112Liquichek1121122016-09-12
00847661000129Liquichek1181182016-09-12
00847661000204Liquichek1291292016-09-12
00847661000211Liquichek1311312016-09-19
00847661000228Liquichek1301302016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656726HealgenHealgen Scientific Limited Liability CompanyJXN2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyJXN2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyJXN2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyJXN2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyJXN2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyJXN2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyJXN2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyJXN2026-06-02
10694644400745INCUPAMERICAN BIO MEDICA CORPORATIONJXN2021-06-24
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONJXN2020-05-29
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXN2019-09-28
10694644400714INCUPAMERICAN BIO MEDICA CORPORATIONJXN2019-03-11
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONJXN2019-02-12
10694644400707INCUPAMERICAN BIO MEDICA CORPORATIONJXN2018-10-29
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXN2018-05-23
10694644400691INCUPAMERICAN BIO MEDICA CORPORATIONJXN2018-04-20
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXN2018-04-19
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONJXN2018-03-30
10694644400684INCUPAMERICAN BIO MEDICA CORPORATIONJXN2018-02-16
10694644200468RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXN2017-10-18
10694644200451RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXN2017-10-12
10694644400677INCUPAMERICAN BIO MEDICA CORPORATIONJXN2017-10-10
10694644200444RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXN2017-06-29
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONJXN2017-06-08
10694644400660INCUPAMERICAN BIO MEDICA CORPORATIONJXN2017-05-05
10694644500230RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONJXN2017-04-25
10694644400653INCUPAMERICAN BIO MEDICA CORPORATIONJXN2017-03-21
10694644500216RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONJXN2017-03-13
10694644500223RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONJXN2017-03-13
10694644500193RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONJXN2017-01-12