FDA.reportPublic FDA data

IDS-iSYS Diluent A

Primary DI
05060169691094
Brand
IDS-iSYS Diluent A
Company
IMMUNODIAGNOSTIC SYSTEMS LIMITED
Model
IS-10DA
Published
2016-04-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060169691094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060169691094050601696910945060169691094

GMDN Terms#

Term, Definition table
TermDefinition
Immunohistochemistry antibody diluent IVDA substance or reactant intended to be used for the dilution of antibody solution for use in an enzyme immunohistochemistry assay performed on biological tissues or clinical specimens.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Special Storage Condition, Specify00Store upon receipt at 2 to 8 degrees celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401915190660info.uk@idsplc.com

Regulatory Flags#

DUNS number
494268600
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060169690721IDS-iSYS Total TestosteroneN/AIS-50002026-04-17
05060169690875IDS-iSYS Total Testosterone Control SetN/AIS-50302026-04-17
05060169691063IDS-iSYS Total Testosterone Calibration VerifiersN/AIS-50352026-04-17
05060169691230IDS-iSYS Free TestosteroneIS-53002025-11-03
05060169691247IDS-iSYS Free Testosterone Control SetIS-53302025-11-03
05060169691254IDS-iSYS Free Testosterone Calibration VerifiersIS-53352025-11-03
05060169693968IDS-i10IS-8104002023-06-27
05060169691223IDS-iSYS Multi Discipline Automated SystemIS-3104002016-04-01
05060169695986IDS Beta CrossLaps® (CTX-I)IS-3000N2024-01-03
05060169696013IDS Beta CrossLaps® (CTX-I) Calibrator SetIS-3020N2024-01-03
05060169696051IDS Beta CrossLaps® (CTX-I) Control SetIS-3030N2024-01-03
05060169696457IDS ACTH IIIS-4500NG2023-08-23
05060169696495IDS ACTH II Calibrator SetIS-4520NG2023-08-23
05060169696532IDS ACTH II Control SetIS-4530NG2023-08-23
05060169691148IDS-iSYS SDSpeed CalcIS-SDSCALC2023-06-27
05060169691261IDS AndrostenedioneIS-54002023-06-27
05060169691278IDS Androstenedione Control SetIS-54302023-06-27
05060169692305IDS-iSYS D-Sorb SolutionIS-DS2002023-06-27
05060169693913IDS Top Cap SetIS-CAP3002023-06-27
05060169696099IDS Androstenedione Calibrator SetIS-54202023-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435389828150SAMPLE PREPARATION KITBIOTECHNOLOGY INSTITUTE SLLXG2026-05-27
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00816394021954Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021985Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021992Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022005Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022012Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022050Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022067Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022074Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022081Helmer ScientificHELMER, INC.LXG2026-05-13
15099590695743iChemVELOCITYBECKMAN COULTER IRELAND INC.LXG2026-04-27
09120123910022Anchor Tips, 300uLSTRATEC Consumables GmbHLXG2026-01-14
26974573531033CellproSuzhou CellPro Biotechnology Co., Ltd.LXG2025-11-21
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10818207025088Endocator Swabs (20pk)Vista DentalLXG2025-11-07
00810100050269KBMEDKB Medical (group), Inc.LXG2025-05-22
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00810100050528KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050535KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050542KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050559KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050603KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050610KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100051297KBMEDKB Medical (group), Inc.LXG2025-05-22
20885380197861CARDINAL HEALTHCardinal Health 200, LLCLXG2025-04-18