FDA.reportPublic FDA data

Asserachrom® ß-TG

Primary DI
03607450009507
Brand
Asserachrom® ß-TG
Company
DIAGNOSTICA STAGO
Model
00950
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JBXAGGREGROMETER, PLATELET

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JBXAggregrometer, PlateletHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K862775000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K862775000ASSERACHROM B-TG KITAmerican Bioproducts Co.1986-10-22JBX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03607450009507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03607450009507036074500095073607450009507

GMDN Terms#

Term, Definition table
TermDefinition
Beta-thromboglobulin IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative detection of beta-thromboglobulin in a clinical specimen, using an enzyme immunoassay (EIA) method. Beta-thromboglobulin is a marker of platelet activation associated with various conditions such as thromboembolism, myocardial infarction and renal disorders.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
262277122
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03607450006766STA® - Coag Control N + ABN006762016-09-15
03607450006773STA® - Coag Control (N + ABN) PLUS006772016-09-15
03607450006780STA® - System Control N + P006782016-09-15
03607450005264STA® - Liatest® Control N + P005262016-09-15
13607450006756STA® - Unicalibrator006752016-09-15
13607450011392Pool Norm011392016-09-15
03607450005400FDP Plasma005402016-09-15
13607450005414FDP Plasma (Latex)005412016-09-15
13607450005513FDP Plasma (Buffer)005512016-09-15
13607450006749STA® - Fibrinogen 5006742016-09-15
03607450589894STA Compact Max® (with cap piercing option)589892016-09-15
03607450589900STA Compact Max®589902016-09-15
03607450590265STA R Max®590262018-10-30
03607450590272STA R Max® (with cap piercing option)590272018-10-30
13607450009757STA® - Desorb U009752020-09-24
03607450009736STA® - Cleaner Solution009732020-09-29
13607450003601STA® - Owren-Koller003602018-09-24
03607450000030STA Coag Expert®V8871112022-12-09
03607450000047Coag.One server licenseV8867652022-12-09
03607450867657Coag.One server licenseV7867652022-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G0561060771Platelet Aggregometer ProfilerBio/Data CorporationJBX2023-08-30
00811476011007CHRONO-LOGCHRONO-LOG CORPJBX2023-06-21
00811476011021CHRONO-LOGCHRONO-LOG CORPJBX2023-06-21
00811476011045CHRONO-LOGCHRONO-LOG CORPJBX2023-06-21
00811476011663CHRONO-LOGCHRONO-LOG CORPJBX2023-06-21
00811476011670CHRONO-LOGCHRONO-LOG CORPJBX2023-06-21
G0561060751Platelet Aggregometer ProfilerBio/Data CorporationJBX2022-03-23
00811476010369Chrono-logCHRONO-LOG CORPJBX2016-10-11
00811476010376Chrono-logCHRONO-LOG CORPJBX2016-10-11
00811476010963Chrono-logCHRONO-LOG CORPJBX2016-10-11
M52553640Arachidonic AcidHELENA LABORATORIES CORPORATIONJBX2016-09-07