FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740011536
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
6L97-20
Catalog number
06L9720
Device description
Propoxyphene
Published
2016-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JXNENZYME IMMUNOASSAY, PROPOXYPHENE

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K943414000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K943414000PROPOXPHENE EIA TESTDiagnostic Reagents, Inc.1994-09-09JXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740011536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740011536003807400115363807400115360380740011536

GMDN Terms#

Term, Definition table
TermDefinition
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature029 Degrees Celsius
Special Storage Condition, Specify00Do not freeze reagents or expose reagent to temperatures above 32 degrees Celsius.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
079226220
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740153694Alinity01R130201R13022023-10-14
00380740153762Alinity04R461204R46122023-10-14
00380740156305ARCHITECT06K460406K46042020-03-03
00380740156381ARCHITECT06K542206K54222020-03-03
00380740156398ARCHITECT06K552306K55232020-03-03
00380740030056ARCHITECT6K46-0206K46022018-07-31
00380740044831ARCHITECT6K54-2106K54212018-07-31
00380740045593ARCHITECT6K55-2206K55222018-07-31
00380740202798Alinity04W560704W56072025-07-21
00380740203108Alinity04W561504W56152025-07-21
00380740203115Alinity04W562504W56252025-07-21
00380740203139Alinity04W566104W56612025-07-21
00380740192402CELL-DYN09H600309H60032020-12-18
00380740020132CELL-DYN09H46-0209H46022016-06-06
00380740020149CELL-DYN09H47-0209H47022016-06-06
00380740020156CELL-DYN09H48-0209H48022016-06-06
00380740120771CELL-DYN09H610109H61012016-09-09
00380740120788CELL-DYN09H62-0109H62012016-09-09
00380740202668Alinity06P010706P01072025-10-03
00380740202828Alinity06P011506P01152025-10-03

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
07290006418326CHROMOSTREAKSAVYON DIAGNOSTICS LTDJXN2026-05-27
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
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