FDA.reportPublic FDA data

Emit II Plus Oxycodone Negative Control 100

Primary DI
00630414028002
Brand
Emit II Plus Oxycodone Negative Control 100
Company
Siemens Healthcare Diagnostics Inc.
Model
10720809
Catalog number
9T609UL
Device description
Emit II Plus Oxycodone Negative Control 100
Published
2018-06-09
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
LASDrug specific control materials

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LASDrug Specific Control MaterialsClinical Toxicology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414028002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414028002006304140280026304140280020630414028002

GMDN Terms#

Term, Definition table
TermDefinition
Oxycodone IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of oxycodone in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Special Storage Condition, Specify00Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
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
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414596167Atellica CH ASO_211097634110976342020-09-24
00630414596259Atellica CH PreAlb11097617110976172020-09-24
00630414596440Atellica CH GGT11097597110975972020-09-24
00630414596174Atellica CH hsCRP11097633110976332017-12-21
00630414596198Atellica CH CRP_211097631110976312017-12-27
00630414597508Atellica CH hsCRP Calibrator11099412110994122017-12-22
00630414597515Atellica CH CRP_2 Calibrator11099430110994302017-12-22
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414611297Atellica CH RCRP Cal11537245115372452024-02-02
00842768037726Dimension EXL LOCI Troponin I High Sensitive10471068104710682019-10-16
00630414596099Atellica CH Thc11097503110975032017-12-27
00630414510156ADVIA® Chemistry PAMY Pancreatic Amylase Reagents1031517814108202016-09-24
00630414595641Atellica CH PAmy11097622110976222017-12-21
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)11538186115381862026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)11538187115381872026-05-29
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414653259Atellica CH Crea311537567115375672026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812101031254ARK™ Apixaban ControlARK DIAGNOSTICS INCLAS2026-09-25
B800BUP5WBFMSP0BUPRENORPHINE 5NG/MLUTAK LABORATORIES, INC.LAS2026-08-27
B800BUS1DPFEUH0BUSULFAN LEVEL 1UTAK LABORATORIES, INC.LAS2026-08-26
B800BUS2DPFEUH0BUSULFAN LEVEL 2UTAK LABORATORIES, INC.LAS2026-08-26
B800BUS3DPFEUH0BUSULFAN LEVEL 3UTAK LABORATORIES, INC.LAS2026-08-26
B800BUS4DPFEUH0BUSULFAN LEVEL 4UTAK LABORATORIES, INC.LAS2026-08-26
B800BUS5DPFEUH0BUSULFAN LEVEL 5UTAK LABORATORIES, INC.LAS2026-08-26
B800BUS6DPFEUH0BUSULFAN LEVEL 6UTAK LABORATORIES, INC.LAS2026-08-26
B07609770LZI Fentanyl Level 1 ControlLIN-ZHI INTERNATIONAL, INC.LAS2026-07-17
B07609780LZI Fentanyl Level 2 ControlLIN-ZHI INTERNATIONAL, INC.LAS2026-07-17
B800FENTHIGHWBSCFL0FENTANYL PLUS HIGHUTAK LABORATORIES, INC.LAS2026-07-14
B800FENTLOWWBSCFL0FENTANYL PLUS LOWUTAK LABORATORIES, INC.LAS2026-07-14
B800LCDOAWBFMSP0DRUGS OF ABUSEUTAK LABORATORIES, INC.LAS2026-07-07
B800THCCTLMFMSP0THC CONTROLUTAK LABORATORIES, INC.LAS2026-07-07
B8007HMG75UFKP07-HMG 75 NG/MLUTAK LABORATORIES, INC.LAS2026-04-02
B800ACETAHIGHV2UADX0ACETAMINOPHEN PLUS HIGH V2UTAK LABORATORIES, INC.LAS2026-01-16
B800ACETALOWV2UADX0ACETAMINOPHEN PLUS LOW V2UTAK LABORATORIES, INC.LAS2026-01-16
B80044600WBF10TCH0BLANK WHOLE BLOOD 10MLUTAK LABORATORIES, INC.LAS2025-10-29
B8006TGRQC1UK06TGR PLUS QC LEVEL 1UTAK LABORATORIES, INC.LAS2025-08-06
B8006TGRQC2UK06TGR PLUS QC LEVEL 2UTAK LABORATORIES, INC.LAS2025-08-06
B8006TGRQC3UK06TGR PLUS QC LEVEL 3UTAK LABORATORIES, INC.LAS2025-08-06
B80088121CDFASC0CERTIFIED DRUG FREE URINEUTAK LABORATORIES, INC.LAS2025-03-24
B80091801UAL0BUPRENORPHINE HYDROLYSIS QCUTAK LABORATORIES, INC.LAS2025-01-13
B80088121CDFL500NPM0CERTIFIED DRUG FREE URINEUTAK LABORATORIES, INC.LAS2024-12-20
B80044600WBF100MLRH0BLANK WHOLE BLOOD 100MLUTAK LABORATORIES, INC.LAS2024-12-11
B80090000UFLTI0NICOTINE PLUS LEVEL 1UTAK LABORATORIES, INC.LAS2024-09-30
B80090001UFLTI0NICOTINE PLUS LEVEL 2UTAK LABORATORIES, INC.LAS2024-09-30
B80088121CDFF10NJSP0CERTIFIED DRUG FREE URINEUTAK LABORATORIES, INC.LAS2024-09-18
B80088121CDFL50PML0CERTIFIED DRUG FREE URINE UTAK LABORATORIES, INC.LAS2024-09-05
B80011511050SMXHFAH0BLANK HAIR MATRIXUTAK LABORATORIES, INC.LAS2024-08-23