FDA.reportPublic FDA data

α-spot

Primary DI
00860802000390
Brand
α-spot
Company
EASTERN BUSINESS FORMS INC
Model
W201
Device description
LFP Alpha-Spot Kit
Published
2021-08-06
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
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860802000397PackageGS17200In Commercial Distribution
00860802000390PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086080200039710860802000397
00860802000390008608020003908608020003900860802000390

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection paperA non-sterile filter-paper card intended to be used as a medium for the collection and transport of blood specimen spots to a laboratory for testing. It provides a uniform surface for the collection of blood spot specimens taken from the patient. Also known as an Ahlstrom 226 specimen collection paper or a Whatman body fluid collection paper, it may incorporate a tear-apart form for demographic information. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079861573
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850039198052903™1052026-04-27
00850039198045903™W2312024-10-11
10850039198042903™W2312024-10-11
00850039198038α-spotW2212024-01-11
10850039198035α-spotW2212024-01-11
00850039198021903™W2212023-05-16
10850039198028903™W2212023-05-16
00850039198007903™W2112022-03-30
00850039198014903™Variable2022-01-28
00860802000383903™W2012021-03-03
10860802000380903™W2012021-03-03
00860802000376903™W1912020-01-17
10860802000373903™W1912020-01-17
00860802000369903™W1812018-12-21
10860802000366903™W1812018-12-21
00860802000352903™W1522018-12-17
00860802000321903™1052018-09-14
00860802000345903™1052018-11-02
00860802000338903™1052018-09-14
10860802000342903™1052018-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536930506BluelineTransparent Supply Solutions Ltd.JKA2026-06-05
00199536930513BluelineTransparent Supply Solutions Ltd.JKA2026-06-05
08887629000008BUHNSP TECH PTE LTDJKA2026-05-29
08887629000053BUCANSP TECH PTE LTDJKA2026-05-29
08887629000060BTANSP TECH PTE LTDJKA2026-05-29
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044793CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044809CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044816CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044823CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044878CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
10197344019649MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-04-23
10197344039715MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-04-17
10197344039708MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-04-16
10197344132911MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-01-23
10197344132928MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-01-23
10850074089060SurgycoSurgyco LLCJKA2025-12-23
10850074089077SurgycoSurgyco LLCJKA2025-12-23
10850074089084SurgycoSurgyco LLCJKA2025-12-23
10850074089091SurgycoSurgyco LLCJKA2025-12-23
10850074089107SurgycoSurgyco LLCJKA2025-12-23
10850074089114SurgycoSurgyco LLCJKA2025-12-23
10612479275635McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
10612479275666McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
10612479275697McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
10612479275727McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14