FDA.reportPublic FDA data

Beckman Coulter PK CMV-PA SYSTEM Control Set

Primary DI
00850212007058
Brand
Beckman Coulter PK CMV-PA SYSTEM Control Set
Company
FUJIREBIO DIAGNOSTICS, INC.
Model
240226
Catalog number
PA2302
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MZETest,Donor,Cmv

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZETest, Donor, CmvUnknown2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK0700300

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0700300

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850212007058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850212007058008502120070588502120070580850212007058

GMDN Terms#

Term, Definition table
TermDefinition
Cytomegalovirus (CMV) total antibody 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 total antibodies to cytomegalovirus (CMV) in a clinical specimen.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-223-0125xx@xx.xx

Regulatory Flags#

DUNS number
079291908
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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00869164000062Serodia TP-PA Kits2349762023-12-06
00869164000079Emit Cyclosporine Sample40080862023-12-06
00869164000000MESOMARK801-9052014-09-17
00869164000048Lumipulse G B-Amyloid Ratio (1-42/1-40) Calculator ToolCL00122022-11-10
00850212007096Lumipulse G Wash Solution40082482017-10-06
00869164000017Lumipulse G ROMACL00042016-09-19
00869164000024ROMA404-10US2016-09-19
00850212007072Fertility Control 21301622020-12-07
00850212007089Vitamin D Control21301662020-07-14
00850212007003FITC Anti-Rabies Monoclonal Globulin800-0922016-09-16
00850212007010Serodia TP-PA16262016-09-16
00850212007027Serodia TP-PA16332016-09-16
00850212007034Vitamin D Control21301522016-09-16
00850212007065Syphilis Control21301702017-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336183069Elecsys Anti-CMVRoche Diagnostics GmbHMZE2023-12-05
07613336182987PreciControl Release Anti-CMVRoche Diagnostics GmbHMZE2023-12-05
07613336228449Elecsys Anti-CMVRoche Diagnostics GmbHMZE2023-12-05
07613336183151PreciControl Anti-CMVRoche Diagnostics GmbHMZE2023-12-05