FDA.reportPublic FDA data

Low-Tox-H Rabbit Complement

Primary DI
00628451099208
Brand
Low-Tox-H Rabbit Complement
Company
Cedarlane Corporation
Model
CL3335
Catalog number
CL3335
Device description
Low-Tox®-H Rabbit Complement, Lyophilized
Published
2024-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KTQReagent, Complement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTQReagent, ComplementImmunology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06284510990202PreviousGS10
00628451099208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
06284510990202062845109902026284510990202
00628451099208006284510992086284510992080628451099208

GMDN Terms#

Term, Definition table
TermDefinition
Complement reagent IVDA solution containing complement proteins intended to be used alone or in combination with other IVDs in the processing, staining and/or testing of clinical laboratory specimens. Typical uses may include HLA tissue typing by a complement-dependent cytotoxicity (CDC) method, or antigen-antibody based reactions by complement fixation test (CFT).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume10Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius-20 Degrees Celsius

Regulatory Flags#

DUNS number
243928822
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06284510990387Augurex Life Sciences90-000590-00052022-12-08
06284510990394Augurex Life Sciences90-003890-00382022-12-08
06284510990400Augurex Life Sciences90-002090-00202022-12-08
06284510990417Augurex Life Sciences90-000990-00092022-12-08
06284510990431Augurex Life Sciences90-002190-00212022-12-08
06284510990448Augurex Life Sciences90-003190-00312022-12-08
06284510990455Augurex Life Sciences90-001390-00132022-12-08
06284510990462Augurex Life Sciences90-001590-00152022-12-08
06284510990479Augurex Life Sciences90-001690-00162022-12-08
00628451099062Standard Rabbit ComplementCL3001CL30012024-12-11
00628451099079Standard Rabbit Complement, FrozenCL3005CL30052024-12-11
00628451099086Standard Rabbit ComplementCL3010-10CL3010-102024-12-11
00628451099093Standard Rabbit ComplementCL3010CL30102024-12-11
00628451099109Standard Rabbit ComplementCL3025CL30252024-12-11
00628451099116Standard Rabbit ComplementCL3050CL30502024-12-11
00628451099123Standard Rabbit ComplementCL3111CL31112024-12-11
00628451099130Standard Rabbit ComplementCL3112CL31122024-12-11
00628451099147Standard Rabbit ComplementCL3113CL31132024-12-11
00628451099154Standard Rabbit ComplementCL3115CL31152024-12-11
00628451099161Standard Rabbit ComplementCL3120CL31202024-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628451099062Standard Rabbit ComplementCedarlane CorporationKTQ2024-12-11
00628451099079Standard Rabbit Complement, FrozenCedarlane CorporationKTQ2024-12-11
00628451099086Standard Rabbit ComplementCedarlane CorporationKTQ2024-12-11
00628451099093Standard Rabbit ComplementCedarlane CorporationKTQ2024-12-11
00628451099109Standard Rabbit ComplementCedarlane CorporationKTQ2024-12-11
00628451099116Standard Rabbit ComplementCedarlane CorporationKTQ2024-12-11
00628451099123Standard Rabbit ComplementCedarlane CorporationKTQ2024-12-11
00628451099130Standard Rabbit ComplementCedarlane CorporationKTQ2024-12-11
00628451099147Standard Rabbit ComplementCedarlane CorporationKTQ2024-12-11
00628451099154Standard Rabbit ComplementCedarlane CorporationKTQ2024-12-11
00628451099161Standard Rabbit ComplementCedarlane CorporationKTQ2024-12-11
00628451099284Standard Rabbit ComplementCedarlane CorporationKTQ2024-12-11
00628451099291Standard Rabbit ComplementCedarlane CorporationKTQ2024-12-11
00628451099178Low-Tox-H Rabbit ComplementCedarlane CorporationKTQ2024-12-10
00628451099185Low-Tox-H Rabbit ComplementCedarlane CorporationKTQ2024-12-10
00628451099192Low-Tox-H Rabbit ComplementCedarlane CorporationKTQ2024-12-10
00628451099215Low-Tox-H Rabbit ComplementCedarlane CorporationKTQ2024-12-10
06284510990066Standard Rabbit ComplementCedarlane CorporationKTQ2022-12-08
06284510990073Standard Rabbit Complement, FrozenCedarlane CorporationKTQ2022-12-08
06284510990080Standard Rabbit ComplementCedarlane CorporationKTQ2022-12-08
06284510990097Standard Rabbit ComplementCedarlane CorporationKTQ2022-12-08
06284510990103Standard Rabbit ComplementCedarlane CorporationKTQ2022-12-08
06284510990110Standard Rabbit ComplementCedarlane CorporationKTQ2022-12-08
06284510990127Standard Rabbit ComplementCedarlane CorporationKTQ2022-12-08
06284510990134Standard Rabbit ComplementCedarlane CorporationKTQ2022-12-08
06284510990141Standard Rabbit ComplementCedarlane CorporationKTQ2022-12-08
06284510990158Standard Rabbit ComplementCedarlane CorporationKTQ2022-12-08
06284510990165Standard Rabbit ComplementCedarlane CorporationKTQ2022-12-08
06284510990172Low-Tox-H Rabbit ComplementCedarlane CorporationKTQ2022-12-08
06284510990189Low-Tox-H Rabbit ComplementCedarlane CorporationKTQ2022-12-08