FDA.reportPublic FDA data

Thermo Scientific Nerl®

Primary DI
00845275004663
Brand
Thermo Scientific Nerl®
Company
Fisher Diagnostics
Model
8505
Published
2019-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JCESolution, Isotonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCESolution, IsotonicPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845275004663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845275004663008452750046638452750046630845275004663

GMDN Terms#

Term, Definition table
TermDefinition
Buffered isotonic saline reagent IVDA buffered isotonic saline solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.

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
800-528-0494Techsupport_diagnostics_mtn@thermo.com

Regulatory Flags#

DUNS number
183998769
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00845275000542Thermo Scientific Pacific Hemostasis®1003562016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810144911304RediporAnalytiChem USA, Inc.JCE2023-09-28
00810144911168RediporAnalytiChem USA, Inc.JCE2023-09-21
00810144911175RediporAnalytiChem USA, Inc.JCE2023-09-21
00810144911182RediporAnalytiChem USA, Inc.JCE2023-09-21
00810144911199RediporAnalytiChem USA, Inc.JCE2023-09-21
00810144911205RediporAnalytiChem USA, Inc.JCE2023-09-21
00810144911212RediporAnalytiChem USA, Inc.JCE2023-09-21
08719189137477RPI-CheckMechatronics USA LLCJCE2022-12-05
08719189137538RPI-CheckMechatronics USA LLCJCE2022-12-05
00845275004366Thermo Scientific Nerl®Fisher DiagnosticsJCE2019-08-26
00845275004342Thermo Scientific Nerl®Fisher DiagnosticsJCE2019-08-13
00845275004656Thermo Scientific Nerl®Fisher DiagnosticsJCE2019-07-31