FDA.reportPublic FDA data

ImmunoCAP Allergen c7, Cefaclor

Primary DI
07333066010427
Brand
ImmunoCAP Allergen c7, Cefaclor
Company
Phadia AB
Model
14-5336-10
Catalog number
14-5336-10
Device description
ImmunoCAP Allergen c7, Cefaclor
Published
2020-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVUReagents, specific, analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333066010427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333066010427073330660104277333066010427

GMDN Terms#

Term, Definition table
TermDefinition
Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of an allergen-specific immunoglobulin E (IgE) antibody in a clinical specimen, using an enzyme immunoassay (EIA) method.

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
+469999999999xx@xx.xx

Regulatory Flags#

DUNS number
354019424
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07333066015507EliA CCP WellDECC066150DECC0661502026-01-29
07333066023908EliA IgG Calibrator WellDECC066090DECC0660902026-01-29
07333066023939EliA Dummy WellDECC066100DECC0661002026-01-29
07333066023977EliA IgA Calibrator WellDECC066160DECC0661602026-01-29
07333066024035EliA IgM Calibrator WellDECC066270DECC0662702026-01-29
07333066024110EliA RF IgM WellDECC067000DECC0670002026-01-29
07333066024134EliA RF IgA WellDECC067010DECC0670102026-01-29
07333066021621Phadia 2500+ LAS Connector12-4008-0212-4008-022023-11-20
07333066003023ImmunoCAP Dummy ImmunoCAP14-4317-0114-4317-012023-07-10
07333066005454ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat14-4954-0114-4954-012022-11-23
07333066010922ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat14-5701-0114-5701-012022-11-23
07333066010991ImmunoCAP Allergen f98, Gliadin14-5752-0114-5752-012022-11-23
07333066021706ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed14-6109-0114-6109-012022-11-23
07333066014876EliA Ro60 WellDECC055250DECC0552502022-09-14
07333066014906EliA Ro52 WellDECC055980DECC0559802022-09-14
07333066022468EliA dsDNA Positive Control 25083-0045-2183-0045-212022-06-23
07333066022475EliA dsDNA Positive Control 2500/500083-0045-3183-0045-312022-06-23
07333066010465ImmunoCAP Allergen o214, Allergen component MUXF3 CCD, Bromelain14-5339-0114-5339-012019-08-14
07333066021355EliA ANA 3 Positive Control 25083-0041-1183-0041-112022-04-07
07333066021362EliA ANA 3 Positive Control 2500/500083-0041-2183-0041-212022-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03661540953118DSQ Alert Measles Primer Mix ASR, 48 rxnElitechgroup Mdx LLCMVU2026-03-24
03661540953125DSQ Alert Measles Probe Mix ASR, 48 rxnElitechgroup Mdx LLCMVU2026-03-24
03661540953132DSQ Alert RNase P Primer Mix ASR 48 rxnElitechgroup Mdx LLCMVU2026-03-24
03661540953163DSQ Alert RNase P Probe Mix ASR 48 rxnElitechgroup Mdx LLCMVU2026-03-24
04251315801035MetaSystems ProbesMetaSystems Probes GmbHMVU2026-03-17
05055844935525CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935532CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935549CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935556CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935563CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935570CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935617CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935624CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
00850051429936Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-02-26
00850051429882Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-01-24
00850051429899Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-01-24
05700575018107Monoclonal Mouse Anti-Human Integrin Beta-6, Clone 6.2A1AGILENT TECHNOLOGIES, INC.MVU2026-01-21
M663DF300120DiskFISHCELLAY, INC.MVU2026-01-06
M663DF300129DiskFISHCELLAY, INC.MVU2026-01-06
M663DF400590DiskFISHCELLAY, INC.MVU2026-01-06
M663DF402440DiskFISHCELLAY, INC.MVU2026-01-06
M663CKOF300120OligoFISHCELLAY, INC.MVU2026-01-06
M663CKOF302510OligoFISHCELLAY, INC.MVU2026-01-06
M663CKOF400590OligoFISHCELLAY, INC.MVU2026-01-06
M663OF4005903001OligoFISHCELLAY, INC.MVU2026-01-06
M663CKOF402440OligoFISHCELLAY, INC.MVU2026-01-06
00810034704009PE anti-human TdTBIOLEGEND, INC.MVU2025-12-22
00810034704016FITC anti-human TdTBIOLEGEND, INC.MVU2025-12-22
00810034704047Pacific Blue™ anti-human Granzyme BBIOLEGEND, INC.MVU2025-12-22
00810034704054Spark Violet™ 538 anti-human HLA-DRBIOLEGEND, INC.MVU2025-12-22