FDA.reportPublic FDA data

Plasma Control

Primary DI
04250317501363
Brand
Plasma Control
Company
Chromsystems Instruments + Chemicals GmbH
Model
0149
Catalog number
0149
Device description
Plasma Control Level II, Olanzapine, Desmethylolanzapine
Published
2020-08-27
Public version status
New
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
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
04250317501363PackageGS110In Commercial Distribution
04250317542823PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250317501363042503175013634250317501363
04250317542823042503175428234250317542823

GMDN Terms#

Term, Definition table
TermDefinition
Multiple antipsychotic 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 multiple antipsychotic drugs, also known as neuroleptic drugs which may include amisulpride, chlorprothixene, melperone and ziprazidone, in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-18 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4989189300mailbox@chromsystems.de

Regulatory Flags#

DUNS number
328712260
Device count
1
DM exempt
false
Premarket exempt
true
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
04250317501554Prefilter15009150092026-01-22
04250317501578Prefilter15011150112026-01-22
04250317536204Prefilter15061150612026-01-22
04250317537577Prefilter15071150712026-01-22
04250317554611Precolumn18010180102026-01-22
04250317555281Prefilter15013150132026-01-22
04250317558022Prefilter57016570162026-01-22
04250317558084Restrictor Capillary55018550182026-01-22
04250317510174Tube48010480102025-07-31
04250317552747Dried Blood Control019501952025-07-31
04250317552754Dried Blood Control019601962025-07-31
04250317552761Dried Blood Control019701972025-07-31
04250317554819Dried Blood Control029502952025-07-31
04250317554826Dried Blood Control029602962025-07-31
04250317554833Dried Blood Control029702972025-07-31
04250317554994Plasma Calibrator Set92025-XT292025-XT22025-07-31
04250317555120Plasma Control0250-XT20250-XT22025-07-31
04250317555144Plasma Control0251-XT20251-XT22025-07-31
04250317555168Plasma Control Bi-Level0249-XT20249-XT22025-07-31
04250317557070Reagent 203320332025-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B800OPIBENZO2V4UFGML0OPI PLUS BENZO LEVEL 2 V4UTAK LABORATORIES, INC.LAS2026-05-26
B800DAU2V2ID5 DRUGS OF ABUSE LEVEL 2 V2UTAK LABORATORIES, INC.LAS2026-03-03
B800DAUHIGHV43MLUIPM0DRUGS OF ABUSE HIGH V4UTAK LABORATORIES, INC.LAS2026-02-25
B800DAULOWV43MLUIPM5 DRUGS OF ABUSE LOW V4UTAK LABORATORIES, INC.LAS2026-02-25
B800DAUMIDV43MLUIPM0DRUGS OF ABUSE MID V4UTAK LABORATORIES, INC.LAS2026-02-25
B800ETH177WBFOSBI5ETHANOL 76 MG/DLUTAK LABORATORIES, INC.LAS2026-02-23
B800ETH76WBFOSBI5ETHANOL 76 MG/DLUTAK LABORATORIES, INC.LAS2026-02-23
B800ANTIF2SQD5ANTIFUNGALS LEVEL 2UTAK LABORATORIES, INC.LAS2026-02-06
B800ANLCCALMFFCCO5 ANLC CALUTAK LABORATORIES, INC.LAS2026-02-05
B800CONTROL1V2SSH5MIXED CONTROL LEVEL 1 V2UTAK LABORATORIES, INC.LAS2026-02-05
B800CONTROL2V2SSH0MIXED CONTROL LEVEL 2 V2UTAK LABORATORIES, INC.LAS2026-02-05
B800DAUCONT1V2FRX5DAU CONTROL LEVEL 1 V2UTAK LABORATORIES, INC.LAS2026-02-05
B800DAUCONT2V2FRX0DAU CONTROL LEVEL 2 V2UTAK LABORATORIES, INC.LAS2026-02-05
B800EIACAL2V2UFRX5 EIA CAL LEVEL 2 V2UTAK LABORATORIES, INC.LAS2026-02-05
B800EIACALLEVEL1V25 EIA CAL LEVEL 1 V2UTAK LABORATORIES, INC.LAS2026-02-05
B800EIANEGV2UFRX5 EIA NEG CAL V2UTAK LABORATORIES, INC.LAS2026-02-05
B800MET1V2WBQD5METALS LEVEL 1 V2UTAK LABORATORIES, INC.LAS2026-02-02
B800MET2V2WBQD5METALS LEVEL 2 V2UTAK LABORATORIES, INC.LAS2026-02-02
B800MET3V2WBQD5METALS LEVEL 3 V2UTAK LABORATORIES, INC.LAS2026-02-02
B800ACETAHIGHV2UADX5ACETAMINOPHEN PLUS HIGH V2UTAK LABORATORIES, INC.LAS2026-01-16
B800ACETALOWV2UADX5ACETAMINOPHEN PLUS LOW V2UTAK LABORATORIES, INC.LAS2026-01-16
B800MOR225UKP5MORPHINE 225 NG/MLUTAK LABORATORIES, INC.LAS2026-01-16
B800AMPH60V2WBCP5AMPH PLUS 60 NG/ML V2UTAK LABORATORIES, INC.LAS2026-01-13
B800DAUL3UFVMCI5 DRUGS OF ABUSE LEVEL 3UTAK LABORATORIES, INC.LAS2026-01-13
B800FENTUFODX5 FENTANYL PLUSUTAK LABORATORIES, INC.LAS2026-01-06
00812101031667ARK™ Ketamine II Control (25/75)ARK DIAGNOSTICS INCLAS2025-12-27
00812101031674ARK™ Ketamine II Control (75/125)ARK DIAGNOSTICS INCLAS2025-12-27
B800AMPQC1URIH5AMPHETAMINE LEVEL 1UTAK LABORATORIES, INC.LAS2025-12-15
B800AMPQC2URIH5AMPHETAMINE LEVEL 2UTAK LABORATORIES, INC.LAS2025-12-15
B800TRAM400UDEAW5TRAMADOL 400 NG/MLUTAK LABORATORIES, INC.LAS2025-09-26