FDA.reportPublic FDA data

CHRONO-PAR

Primary DI
00811476010055
Brand
CHRONO-PAR
Company
CHRONO-LOG CORP
Model
385
Device description
Collagen
Published
2016-10-11
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
GHRReagent, Platelet Aggregation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GHRReagent, Platelet AggregationHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K922800000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K922800000PLATELET AGGREGATION REAGENTSChrono-Log Corp.1992-08-26GHR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811476010055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811476010055008114760100558114760100550811476010055

GMDN Terms#

Term, Definition table
TermDefinition
Platelet aggregation study IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative evaluation of platelet aggregation in a clinical specimen using one or multiple platelet aggregation agents, which may include adenosine diphosphate, collagen, epinephrine, thrombin, arachidonic acid and/or ristocetin.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
610-853-1130chronolog@chronolog.com

Regulatory Flags#

DUNS number
002353696
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
00811476011007CHRONO-LOGAGGRO/LINK WBA Software2023-06-21
00811476011021CHRONO-LOGAGGRO/LINK8 Software2023-06-21
00811476011045CHRONO-LOGvW CoFactor Software2023-06-21
00811476011663CHRONO-LOGAGGRO/LINK Opti8 Software2023-06-21
00811476011670CHRONO-LOGvW CoFactor Opti8 Software2023-06-21
00811476010246Chrono-log490490-2D2016-10-11
00811476010253Chrono-log490490-X2016-10-11
00811476010369Chrono-log590590-2D2016-10-11
00811476010376Chrono-log590590-X2016-10-11
00811476010383Chrono-log5915912016-10-11
00811476010390Chrono-log591A591A2016-10-11
00811476010406Chrono-log5925922016-10-11
00811476010413Chrono-log592592-X2016-10-11
00811476010420Chrono-log592A592A2016-10-11
00811476010437Chrono-log592A592A-X2016-10-11
00811476010482Chrono-log700700-22016-10-11
00811476010499Chrono-log700700-X2016-10-11
00811476010956Chrono-log490490-4D2016-10-11
00811476010963Chrono-log590590-4D2016-10-11
00811476010987Chrono-log490 4+490 4+2016-12-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811476010048CHRONO-PARCHRONO-LOG CORPGHR2016-10-11
00811476010062CHRONO-PARCHRONO-LOG CORPGHR2016-10-11
00811476010086CHRONO-PARCHRONO-LOG CORPGHR2016-10-11
00811476010147CHRONO-PARCHRONO-LOG CORPGHR2016-10-11
15391521420067Adenosine Diphosphate (ADP)TCOAG IRELAND LIMITEDGHR2016-09-12
15391521420081Ristocetin (7.5 mg/vial)TCOAG IRELAND LIMITEDGHR2016-09-12
M52553660ADP ReagentHELENA LABORATORIES CORPORATIONGHR2016-09-07
M52553670Epinephrine ReagentHELENA LABORATORIES CORPORATIONGHR2016-09-07
M52553680Collagen ReagentHELENA LABORATORIES CORPORATIONGHR2016-09-07
M52553690Platelet Aggregation KitHELENA LABORATORIES CORPORATIONGHR2016-09-07
M52558640Plateletworks Arachidonic Acid KitHELENA LABORATORIES CORPORATIONGHR2016-09-07