FDA.reportPublic FDA data

Immunalysis

Primary DI
00840937112137
Brand
Immunalysis
Company
IMMUNALYSIS CORP
Model
612OF-0500
Catalog number
612OF-0500
Device description
SEFRIA™ Benzoylecgonine Oral Fluid
Published
2021-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
PVATest, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PVATest, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, ExemptClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840937112137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840937112137008409371121378409371121370840937112137

GMDN Terms#

Term, Definition table
TermDefinition
Cocaine/cocaine metabolite 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 cocaine and/or cocaine metabolites 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
+1(909)482-0840info@immunalysis.com

Regulatory Flags#

DUNS number
002804244
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
00840937114636Immunalysis10063-1510063-152024-04-19
00840937114643Immunalysis10064-1510064-152024-04-19
00840937114650Immunalysis10065-1510065-152024-04-19
00840937114667Immunalysis10066-1510066-152024-04-19
00840937114674Immunalysis3020-153020-152024-04-19
00840937114568Immunalysis10068-1510068-152024-04-08
00840937114605ImmunalysisNegOFLP-0100NegOFLP-01002024-04-08
00840937103265Immunalysis10047-1010047-102023-10-26
00840937103272Immunalysis10048-1010048-102023-10-26
00840937103289Immunalysis10049-1010049-102023-10-26
00840937103296Immunalysis10050-1010050-102023-10-26
00840937112076Immunalysis3017-103017-102021-02-05
00840937112083Immunalysis10054-1010054-102021-02-05
00840937112090Immunalysis10053-1010053-102021-02-05
00840937112106Immunalysis10052-1010052-102021-02-05
00840937112113Immunalysis10051-1010051-102021-02-05
00840937111895Immunalysis10055-1010055-102020-03-31
00840937111918Immunalysis10056-1010056-102020-03-31
00840937111925Immunalysis10057-1010057-102020-03-31
00840937111932Immunalysis10058-1010058-102020-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPVA2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPVA2026-04-29
G474M310501EI0mLife ClassicMlife Diagnostics, LLCPVA2026-04-03
B29880913EI0DrugCheck Express Diagnostic Int'l, Inc.PVA2026-02-23
B29880502EI0DrugCheck Express Diagnostic Int'l, Inc.PVA2026-02-20
G474M321001EI0mLife VerifyMlife Diagnostics, LLCPVA2026-01-29
00810174470963PRIME SCREEN®WONDFO USA CO., LTD.PVA2025-12-05
00810174471007PRIME SCREEN®WONDFO USA CO., LTD.PVA2025-12-05
00810174471182SAFElife™WONDFO USA CO., LTD.PVA2025-12-05
00810174471212PRIME SCREEN®WONDFO USA CO., LTD.PVA2025-12-05
00810174471175SAFElife™WONDFO USA CO., LTD.PVA2025-12-05
00810174471199PRIME SCREEN®WONDFO USA CO., LTD.PVA2025-12-05
00810174471144PRIME SCREEN®WONDFO USA CO., LTD.PVA2025-12-03
00810174471168PRIME SCREEN®WONDFO USA CO., LTD.PVA2025-12-03
G474M3209010VerifyMlife Diagnostics, LLCPVA2025-09-05
G474M3208010VerifyMlife Diagnostics, LLCPVA2025-07-21
00816862026634Prime ScreenWONDFO USA CO., LTD.PVA2025-07-03
G474M3106010ClassicMlife Diagnostics, LLCPVA2025-06-20
G474M3105010ClassicMlife Diagnostics, LLCPVA2025-06-19
00816862026337SAFElife™WONDFO USA CO., LTD.PVA2025-05-19
G474MC002080001EI0ClassicMlife Diagnostics, LLCPVA2025-03-19
06977469280219S-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold)Eterbio, Inc.PVA2024-12-18
G474MC001050002EI0ClassicMlife Diagnostics, LLCPVA2024-11-05
G474MV002110001EI0VerifyMlife Diagnostics, LLCPVA2024-10-08
00850054867704AmazewellGuangzhou Decheng Biotechnology Co., LTDPVA2024-09-30
00850054867711AmazewellGuangzhou Decheng Biotechnology Co., LTDPVA2024-09-30
00850054867728AmazewellGuangzhou Decheng Biotechnology Co., LTDPVA2024-09-30
00850054867735AmazewellGuangzhou Decheng Biotechnology Co., LTDPVA2024-09-30
00850054867896AmazewellGuangzhou Decheng Biotechnology Co., LTDPVA2024-09-29
00850054867964AmazewellGuangzhou Decheng Biotechnology Co., LTDPVA2024-09-29