FDA.reportPublic FDA data

Birlinn BCR-ABL1 p210 IS Control Panel C240

Primary DI
00852720008367
Brand
Birlinn BCR-ABL1 p210 IS Control Panel C240
Company
Mmqci
Model
v.00
Catalog number
C240
Device description
External quality controls to monitor the performance of in vitro laboratory nucleic acid detection and quantification of BCR-ABL1 fusion gene using molecular test systems.
Published
2025-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QIGQuality Control Material, Genetics, Rna

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QIGQuality Control Material, Genetics, RnaMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852720008367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852720008367008527200083678527200083670852720008367

GMDN Terms#

Term, Definition table
TermDefinition
Philadelphia chromosome/BCR-ABL transcript IVD, controlA material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict chronic myeloid leukaemia (CML) or a subset of acute lymphoblastic leukaemia (ALL) associated with the Philadelphia chromosome, resulting from translocation t(9;22)(q34;q11) and rearrangement of the BCR and ABL genes.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius-15 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
207-885-1072info@mmqci.com

Regulatory Flags#

DUNS number
172874245
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852720008244Birlinn™ CoV2-Flu-RSV Control Panel M509v.00M5092025-12-04
00852720008275FilmArray GI Control Panel M238v.00M2382025-12-04
00852720008336Birlinn BCR-ABL1 p210 IS Panel C230v.00C2302025-06-20
00852720008145SPOTFIRE RSP Pos & Neg Controlsv.00M4252025-06-18
00852720008442Xpert BCR-ABL IS p210 Panel C206v.00C2062025-06-18
00852720008091SPOTFIRE RSP Positive Controlv.00M426382023-09-15
00852720008107SPOTFIRE RSP Negative Controlv.00M427382023-09-15
00852720008114BioFire RP2.1/RP2.1plus Control Panel M441v.00M4412021-09-16
00852720008046FilmArray RP EZ Control Panel M265v.00M2652020-01-22
00852720008039FilmArray RP2/RP2plus Control Panelv.00M3152019-12-31
00852720008183Xpert BCR-ABL IS p210 Linearity Panel C207v.00C2072023-09-15
00852720008121BioFire JI Control Panel M420v.00M4202022-11-14
00852720008077FilmArray BCID2 Control Panel M416v.00M4162021-02-18
00852720008053FilmArray Warrior Control Panel M290v.00M2902020-11-24
00852720008022FilmArray Pneumonia/Pneumoniaplus Controlv.00M3402019-06-17
00852720008084Xpert BCR-ABL 0%ISv.00C13112-52020-01-27
00852720008015INTROL CF Panel I Controlv.02G106ac2019-12-24
00852720008008INTROL CF Panel I Controlv.02G106ac-12019-12-05
00852720008060Xpert BCR-ABL IS Panel C130v.00C1302019-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852720008336Birlinn BCR-ABL1 p210 IS Panel C230MmqciQIG2025-06-20
00852720008442Xpert BCR-ABL IS p210 Panel C206MmqciQIG2025-06-18
00852720008183Xpert BCR-ABL IS p210 Linearity Panel C207MmqciQIG2023-09-15
00852720008084Xpert BCR-ABL 0%ISMmqciQIG2020-01-27
00852720008060Xpert BCR-ABL IS Panel C130MmqciQIG2019-12-04