FDA.reportPublic FDA data

KaiBiLi Extended ViralTrans Saline

Primary DI
06972698600524
Brand
KaiBiLi Extended ViralTrans Saline
Company
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
Model
M221125
Device description
5 mL
Published
2022-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JSGCulture Media, Non-Selective And Non-Differential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSGCulture Media, Non-Selective And Non-DifferentialMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26972698600528PackageGS18In Commercial Distribution
16972698600521PrimaryGS10
06972698600524Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697269860052826972698600528
1697269860052116972698600521
06972698600524069726986005246972698600524

GMDN Terms#

Term, Definition table
TermDefinition
General specimen collection kitA collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium [e.g., preservation solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
547938709
Device count
50
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
16972698600408KaiBiLi Extended ViralTrans PBSM2211132024-02-05
16972698600415KaiBiLi Extended ViralTrans PBSM2211142024-02-05
16972698600354KaiBiLi Extended ViralTransM2210112024-02-07
16972698600361KaiBiLi Extended ViralTransM2210122024-02-07
26972698600351KaiBiLi Extended ViralTransM2210112024-02-07
26972698600368KaiBiLi Extended ViralTransM2210122024-02-07
16972698600293KaiBiLi Extended ViralTransM2210012024-02-05
16972698600316KaiBiLi Extended ViralTransM2210072024-02-05
16972698600323KaiBiLi Extended ViralTransM2210082024-02-05
16972698600330KaiBiLi Extended ViralTransM2210092024-02-05
16972698600347KaiBiLi Extended ViralTransM2210102024-02-05
06972698600296KaiBiLi Extended ViralTransM2210012024-02-05
16972698600309KaiBiLi Extended ViralTransM2210062024-02-05
06972698600319KaiBiLi Extended ViralTransM2210072024-02-05
06972698600326KaiBiLi Extended ViralTransM2210082024-02-05
26972698600337KaiBiLi Extended ViralTransM2210092024-02-05
26972698600344KaiBiLi Extended ViralTransM2210102024-02-05
26972698600405KaiBiLi Extended ViralTrans PBSM2211132024-02-05
26972698600412KaiBiLi Extended ViralTrans PBSM2211142024-02-05
16972698600521KaiBiLi Extended ViralTrans SalineM2211252022-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B645T0466EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-21
B645T0486EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-21
B645T0749EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-21
B645T0759EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-21
B6451B265EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B6451R007EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B645GB477EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B645T0006EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B645T0246EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-18
B6452P195EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B6454P145EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B6454P459EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B645GB285EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B645T0448EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
B645T0487EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSG2025-04-17
10382902212611BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood (TSA II)BECTON, DICKINSON AND COMPANYJSG2024-08-23
16972698600408KaiBiLi Extended ViralTrans PBSHangzhou Genesis Biodetection & Biocontrol Co., LTD.JSG2024-02-05
16972698600415KaiBiLi Extended ViralTrans PBSHangzhou Genesis Biodetection & Biocontrol Co., LTD.JSG2024-02-05
30382902976425BD BBL™ Fluid Thioglycollate Medium, EnrichedBECTON, DICKINSON AND COMPANYJSG2023-11-14
18053326001021BHI BROTHCOPAN ITALIA SPAJSG2023-03-03
00848838002878REMELREMEL, INC.JSG2022-12-23
00848838002946REMELREMEL, INC.JSG2022-12-23
00848838002960REMELREMEL, INC.JSG2022-12-23
00848838003363REMELREMEL, INC.JSG2022-12-23
00848838003394REMELREMEL, INC.JSG2022-12-23
00848838003721REMELREMEL, INC.JSG2022-12-23
00848838003912REMELREMEL, INC.JSG2022-12-23
00848838004537REMELREMEL, INC.JSG2022-12-23
00848838004575REMELREMEL, INC.JSG2022-12-23
00848838004612REMELREMEL, INC.JSG2022-12-23