FDA.reportPublic FDA data

Instant-View HCG Midstream Cassette

Primary DI
00766918000012
Brand
Instant-View HCG Midstream Cassette
Company
ALFA SCIENTIFIC DESIGNS, INC.
Model
02-2480
Device description
HCG Midstream Cassette
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LCXKit, Test, Pregnancy, Hcg, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCXKit, Test, Pregnancy, Hcg, Over The CounterClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00766918000012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00766918000012007669180000127669180000120766918000012

GMDN Terms#

Term, Definition table
TermDefinition
Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of total human chorionic gonadotropin (HCG), which may include intact HCG, nicked HCG, free alpha-HCG subunits and/or free beta-HCG subunits, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
176391167
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
00796918002440Multi-Drug of Abuse Urine Cup Test03-46802022-11-07
00796918002433Instant-View Multi-Drug of Abuse Urine Cup Test AMP BZD COC MET MOR/OPI PCP THC03-44392021-09-24
00796918002426INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET, MOR30003-39482021-07-29
00796918002419INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET,MOR, MTD, OXY, T03-3803QW2021-07-12
00796918002204INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR30003-39422021-04-21
00796918002198INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BUP, BZD, COC, MOR3003-39452020-09-14
20796918001904INSTANT-VIEW FOB Test - complete kit, 25 test05-7601-252019-07-01
30796918001901INSTANT-VIEW FOB Test - complete kit, 50 test05-7601-502019-07-01
10796918002096INSTANT-VIEW FOB Test05-7602-502019-05-01
10796918001778INSTANT-VIEW FOB Test05-76022016-09-23
10796918001785INSTANT-VIEW FOB Test05-7602-22016-09-23
10796918001907INSTANT-VIEW FOB Test05-76022017-04-10
10796918001914Instant-view plus Immunochemical Fecal Occult Blood Test05-76322018-08-28
10796918001921Instant-view plus Immunochemical Fecal Occult Blood Test05-7632OT2018-08-28
10796918002188INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MOR300, THC03-35512019-09-23
10796918002171INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MET, MOR300, THC03-34622019-06-12
10796918002157INSTANT-VIEW LH Midstream Cassette Test, 6 tests02-2540-62019-06-03
10796918002164INSTANT-VIEW FSH Midstream Cassette Test02-25602019-06-03
10796918002140 Instant-View HCG Midstream Cassette, 2t02-2480-22019-05-30
10796918002119INSTANT-VIEW Marijuana (THC) Urine Dip Cassette Test03-3072OT-52019-05-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810164510006ACESO Early Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
80810164510019ACESO Early Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
80810164510026ACESO Early Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
80810164510033ACESO Early Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
80810164510040ACESO Early Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
80810164510057ACESO Early Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
80810164510064ACESO Early Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
00810164510112Atida Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
00810164510129Atida Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
00810164510150Atida Digital Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
00810164510693Atida Early Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
00810164510709Atida DIGITAL EARLY PREGNANCY TESTACESO LABORATORIES INC.LCX2026-03-23
00812203030889ChemtrueCHEMTRON BIOTECH INCLCX2026-03-10
00072036704283Harris TeeterHarris Teeter, LLCLCX2026-02-27
00072036714299Harris TeeterHarris Teeter, LLCLCX2026-02-27
30075450847636Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
00075450847642Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
00075450847659Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
30075450847667Hy-Vee® Analog Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
30075450847674Hy-Vee® Digital Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
10751774000037DG HealthDOLGENCORP, LLCLCX2026-02-20
10311917083800WalgreensWALGREEN CO.LCX2026-02-17
10311917083954WalgreensWALGREEN CO.LCX2026-02-17
10311917084029WalgreensWALGREEN CO.LCX2026-02-17
00070552251120Winco Foods One Step Pregnancy TestWINCO FOODS, LLCLCX2026-02-09
00070552351134Winco Foods One Step Pregnancy TestWINCO FOODS, LLCLCX2026-02-09
10311917083459WalgreensWALGREEN CO.LCX2026-02-05
10311917083510WalgreensWALGREEN CO.LCX2026-02-05
10311917083572WalgreensWALGREEN CO.LCX2026-02-05
50045611010005SURESIGN™ Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-01-28