FDA.reportPublic FDA data

QMS Plazomicin Immunoassay Control

Primary DI
00884883006980
Brand
QMS Plazomicin Immunoassay Control
Company
Microgenics Corporation
Model
10023697
Published
2019-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00884883006980PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884883006980008848830069808848830069800884883006980

GMDN Terms#

Term, Definition table
TermDefinition
Plazomicin therapeutic drug monitoring IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of the antimicrobial drug plazomicin in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
122153799
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
00884883006751DRI Ecstasy Plus Assay100246312018-09-27
00884883001558CEDIA Heroin Metabolite (6-AM) Assay1001072016-09-26
00884883004245CEDIA Heroin Metabolite (6-AM) Assay1001082016-09-22
00884883004306CEDIA Heroin Metabolite (6-AM) Assay1001862016-09-21
00884883011366CEDIA Heroin Metabolite (6-AM) Assay100152132016-09-21
00884883009301MAS Omni•IMMUNE Max, Level 1OIMM-1012025-08-12
00884883009318MAS Omni•IMMUNE Max, Level 2OIMM-2022025-08-12
00884883009325MAS Omni•IMMUNE Max, Level 3OIMM-3032025-08-12
00884883009332MAS Omni•IMMUNE Max, Sample PackOIMM-SP2025-08-12
00884883009349MAS Omni•IMMUNE PRO Max, Level 1OPROM-1012025-08-12
00884883009356MAS Omni•IMMUNE PRO Max, Level 2OPROM-2022025-08-12
00884883009363MAS Omni•IMMUNE PRO Max, Level 3OPROM-3032025-08-12
00884883009370MAS Omni•IMMUNE PRO Max, Sample PackOPROM-SP2025-08-12
00884883009257MAS OmniCORE Max, Level 1OCRM-1012025-06-27
00884883009264MAS OmniCORE Max, Level 2OCRM-2022025-06-27
00884883009271MAS OmniCORE Max, Level 3OCRM-3032025-06-27
00884883009288MAS OmniCORE Max, Sample PackOCRM-SP2025-06-27
00884883009219MAS Omni-Core II Liquid Assayed Integrated Chemistry Control 1OCRL-1012025-01-31
00884883009226MAS Omni-Core II Liquid Assayed Integrated Chemistry Control 2OCRL-2022025-01-31
00884883009233MAS Omni-Core II Liquid Assayed Integrated Chemistry Control 3OCRL-3032025-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
B800AED1V3SHCMC0AED LEVEL 1 V3UTAK LABORATORIES, INC.LAS2025-08-25
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
B800AEDSSCH0AED PLUSUTAK LABORATORIES, INC.LAS2024-07-17
B80044600WBFPOSAFT0POSITIVE WHOLE BLOODUTAK LABORATORIES, INC.LAS2024-05-20
B80088121CDFF10FS0CERTIFIED DRUG FREE URINEUTAK LABORATORIES, INC.LAS2024-05-06
B8007AMINOHIGHUPM07-AMINOCLONAZEPAM HIGHUTAK LABORATORIES, INC.LAS2024-05-03
B8007AMINOLOWUPM07-AMINOCLONAZEPAM LOWUTAK LABORATORIES, INC.LAS2024-05-03
B80088121CDFF100PDH0CERTIFIED DRUG FREE URINE 100MLUTAK LABORATORIES, INC.LAS2024-04-30
B80066815V3HRLC0HIGH RANGE TRACE ELEMENTS V3UTAK LABORATORIES, INC.LAS2024-04-03
B80066816V3NRLC0NORMAL RANGE TRACE ELEMENTS V3UTAK LABORATORIES, INC.LAS2024-04-03
B800ACETAUV4PM0ACETAMINOPHEN PLUS V4UTAK LABORATORIES, INC.LAS2024-03-12
B80092021IDC0SSRI 12 LEVEL 2UTAK LABORATORIES, INC.LAS2024-03-06
B800ACE250SFBSRHS0ACETONE 250 MG/DLUTAK LABORATORIES, INC.LAS2024-02-27
B80088121CDFLLTRWVDTL0CERTIFIED DRUG FREE URINEUTAK LABORATORIES, INC.LAS2024-02-20
B800ACIDNEUTQC0ACID-NEUT QCUTAK LABORATORIES, INC.LAS2024-02-16