FDA.reportPublic FDA data

Thermo Scientific Protocol™ Parasitology System

Primary DI
00845275005011
Brand
Thermo Scientific Protocol™ Parasitology System
Company
Fisher Diagnostics
Model
23-005-38
Published
2016-09-16
Public version status
Update
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
HYWStain, Trichrome, Mallory'S

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HYWStain, Trichrome, Mallory'SHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845275005011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845275005011008452750050118452750050110845275005011

GMDN Terms#

Term, Definition table
TermDefinition
Trichrome Blue/Ryan Blue solution IVDA trichrome blue or Ryan blue solution intended to be used alone, or in combination with other solutions/stains, for the visualization of biological/clinical specimen tissue structures and/or intra/extracellular elements.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-528-0494xx@xx.xx

Regulatory Flags#

DUNS number
183998769
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845275002751Thermo Scientific Infinity™TR254212016-09-16
00845275000504Thermo Scientific Pacific Hemostasis®1003012016-09-16
00845275000559Thermo Scientific Pacific Hemostasis®1005952016-09-16
00845275000566Thermo Scientific Pacific Hemostasis®1005962016-09-16
00845275000573Thermo Scientific Pacific Hemostasis®1005972016-09-16
00845275000580Thermo Scientific Pacific Hemostasis®1006012016-09-16
00845275000634Thermo Scientific Pacific Hemostasis®1003082016-09-16
00845275000658Thermo Scientific Pacific Hemostasis®1003122016-09-16
00845275000818Thermo Scientific Pacific Hemostasis®1005602016-09-16
00845275000832Thermo Scientific Pacific Hemostasis®1006032016-09-16
00845275000849Thermo Scientific Pacific Hemostasis®1006062016-09-16
00845275000016Infinity Ammonia Reagent for Beckman Coulter AU Chemistry Analyzers OSR611542025-11-18
00845275000405Thermo Scientific TR360262016-09-16
00845275001068Thermo Scientific 12452502016-09-16
00845275002973Thermo Scientific TR333212016-09-16
00845275005431Thermo Scientific for Beckman Coulter SYNCHRON and UnuCel SystemsA466602016-09-16
00845275004717Thermo Scientific Nerl®JDIL55222019-08-13
00845275003031Thermo Scientific Infinity™TR351212016-09-16
00845275000528Thermo Scientific Pacific Hemostasis®1003532016-09-16
00845275000535Thermo Scientific Pacific Hemostasis®1003542016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00673693089869EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYW2024-09-05
00673693169028EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYW2024-09-05
00673693169042EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYW2024-09-05
00673693089845EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYW2024-09-04
00673693169035EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYW2024-09-04
00840733103452Trichrome StainMERIDIAN BIOSCIENCE, INC.HYW2021-07-07
00840733102547EcoStainMERIDIAN BIOSCIENCE, INC.HYW2020-12-09
00840733102585Hemo-DeMERIDIAN BIOSCIENCE, INC.HYW2020-12-09
00840733101960Para-Pak TRICHROME STAINMERIDIAN BIOSCIENCE, INC.HYW2020-10-06
00840733102431Trichrome StainMERIDIAN BIOSCIENCE, INC.HYW2020-09-21
00840733102660Modified Hemo-DeMERIDIAN BIOSCIENCE, INC.HYW2020-09-21