FDA.reportPublic FDA data

Emit® II Plus Methaqualone Assay

Primary DI
00842768023453
Brand
Emit® II Plus Methaqualone Assay
Company
Siemens Healthcare Diagnostics Inc.
Model
10445476
Catalog number
9Q229
Device description
Emit® II Plus Methaqualone Assay labeled with the Beckman Coulter® name
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KXSRADIOIMMUNOASSAY, METHAQUALONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXSRadioimmunoassay, MethaqualoneClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011164000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011164000MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229Syva Co., Dade Behring, Inc.2001-05-10KXS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768023453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768023453008427680234538427680234530842768023453

GMDN Terms#

Term, Definition table
TermDefinition
Methaqualone 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 methaqualone in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-8994XX@XX.XX
+1(800)227-8994CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414124797ADVIA Centaur® Calibrator D10311569103115692014-09-24
00630414124933ADVIA Centaur® Systems, ACS:180® Systems Calibrator D10311576103115762014-09-24
00630414126319ADVIA Centaur® Systems, ACS 180® Systems AFP MCM10311625103116252014-09-24
00630414177335ADVIA Centaur® AFP10309980103099802014-09-24
00630414238791Atellica IM AFP11202257112022572018-11-14
00630414238807Atellica IM AFP11202258112022582018-11-14
00630414597720Atellica IM AFP MCM10995443109954432018-11-14
00630414279176ADVIA Chemistry UCFP11319151113191512020-03-06
00630414209845ADVIA® Chemistry MG Magnesium Reagents10341119103411192020-09-24
00630414474748ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents10309071103090712020-09-24
00630414508399ADVIA® Chemistry IP Inorganic Phosphorus Reagents10309503103095032020-09-24
00630414508429ADVIA® Chemistry MG Magnesium Reagents10309506103095062020-09-24
00630414561073ADVIA® Chemistry CHOL_2 Cholesterol_2 Reagent10376501103765012020-09-24
00630414561974ADVIA® Chemistry IRON_2 Iron 2 Reagents10377510103775102020-09-24
00630414279183ADVIA Chemistry UCFP Calibrator11319152113191522020-03-06
00842768013836Dimension Cardiac Troponin-I Flex reagent cartridge10444905104449052016-09-24
00842768013904Dimension Cardiac Troponin-I Flex reagent cartridge10444896104448962016-09-24
00630414008967ADVIA® Chemistry Enzyme 1 Calibrator10916057109160572016-09-24
00630414177328ADVIA Centaur® AFP10309979103099792014-09-24
00630414553153ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated10283343102833432016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336166109ONLINE DAT MethaqualoneRoche Diagnostics GmbHKXS2020-03-05
00842768002205Syva® Emit® II Plus Methaqualone AssaySiemens Healthcare Diagnostics Inc.KXS2016-09-24
00842768002212Syva® Emit® II Plus Methaqualone AssaySiemens Healthcare Diagnostics Inc.KXS2016-09-24
00842768014437Syva® Emit® II Plus Methaqualone AssaySiemens Healthcare Diagnostics Inc.KXS2016-09-24
04015630993529MethaqualoneRoche Diagnostics GmbHKXS2016-09-20
04015630998951MethaqualoneRoche Diagnostics GmbHKXS2016-09-20
00884883002937DRI Methaqualone AssayMicrogenics CorporationKXS2016-09-12
00884883003415DRI Methaqualone AssayMicrogenics CorporationKXS2016-09-12
15099590222987SynchronBeckman Coulter, Inc.KXS2016-08-24