Atellica CH Thc

Primary DI
00630414596099
Brand
Atellica CH Thc
Company
Siemens Healthcare Diagnostics Inc.
Model
11097503
Catalog number
11097503
Device description
Cannabinoids (Thc) Atellica CH - RGT 1520T
Published
2017-12-27
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LDJEnzyme immunoassay, cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993984000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993984000SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129ULSyva Co.2000-01-18LDJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414596099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414596099006304145960996304145960990630414596099

GMDN Terms#

Term, Definition table
TermDefinition
Cannabinoid/cannabinoid metabolite 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 cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414482446ADVIA® Chemistry LIP Lipase Reagents10311896103118962020-09-24
00630414510149ADVIA® Chemistry CHE Cholinesterase Reagents10315176103151762020-09-24
00630414526829ADVIA® Chemistry TRIG_2 Triglyceride_2 Reagent10335892103358922020-09-24
00630414553191ADVIA® Chemistry IP_c Inorganic Phosphorus Reagent, Concentrated10283347102833472020-09-24
00842768013713Dimension® CTNI Calibrator10444986104449862016-09-24
00842768016936Dimension N-terminal Pro-Brain Natriuretic Peptide reagent cartridge10444901104449012016-09-24
00630414482385ADVIA® Chemistry RF Rheumatoid Factor Reagents10311894103118942016-09-24
00630414513096ADVIA® Chemistry CA_2 Calcium Reagents (Arsenazo III)10316612103166122016-09-24
00630414513102ADVIA® Chemistry CA_2 Calcium_2 Reagents (Arsenazo III)10341116103411162016-09-24
00630414517742ADVIA® Chemistry C4 Complement C4 Reagents10309054103090542016-09-24
00630414590394ADVIA® Chemistry TRIG_c Reagent10697575106975752016-09-24
00630414601199ADVIA® Chemistry Alkaline Phosphatase (ALP_2) Calibrator10916060109160602016-09-24
00630414947419ADVIA® Chemistry Albumin BCP Reagents10711841107118412016-09-24
00630414947426ADVIA® Chemistry Albumin BCP Calibrator10711842107118422016-09-24
00630414465401ADVIA® Chemistry CHE Cholinesterase Reagents10329639103296392020-09-24
00630414534794ADVIA® 1800 Analyzer10315183103151832020-09-24
00630414000510VERSANT HCV Control 2.0 Kit (LiPA)10719668107196682017-09-15
00630414454597ADVIA Centaur® FOL10331250103312502016-09-24
00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
00630414569277ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents10379635103796352016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00894175000091QMedix™Diagnostic Automation, Inc.LDJ2026-09-30
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.LDJ2026-09-24
00817405024247iScreen™Instant Technologies, Inc.LDJ2026-08-01
00810173656719HealgenHealgen Scientific Limited Liability CompanyLDJ2026-07-31
00841824104167ECOIIW.H.P.M. INC.LDJ2026-07-07
00810173656726HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyLDJ2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035554Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035691Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035707Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10722066008369Rapid ResponseBTNX IncLDJ2024-02-26
16936983149751Discover milti-drug12 drugs rapid test cupHangzhou AllTest Biotech Co., Ltd.LDJ2024-02-09